Becton, Dickinson and Company, BD Bio Sciences Recalls

All product recalls associated with Becton, Dickinson and Company, BD Bio Sciences.

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Recall Summary

Total Recalls

16

Past Year

3

Class I (Serious)

0

Most Recent

Jul 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–16 of 16 recalls

BD Trucount Controls (BD Bio Sciences) – Incorrect SD Values (2025)

Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.

Moderate

FDAJul 8, 2025Nationwide• Becton, Dickinson and Company, BD Bio Sciences

BD FACS Setup Beads (Becton Dickinson) – Spectral Overlap Error (2025)

Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.

Moderate

FDAJun 3, 2025AZ, AR, CA +34 more• Becton, Dickinson and Company, BD Bio Sciences

BD FACS Setup Beads (Becton Dickinson) – Spectral Overlap Error (2025)

Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.

Moderate

FDAJun 3, 2025AZ, AR, CA +34 more• Becton, Dickinson and Company, BD Bio Sciences

FACSLyric 3L10C Instrument (BD) – power supply module issue (2024)

On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.

Moderate

FDANov 1, 2024Nationwide• Becton, Dickinson and Company, BD Bio Sciences

FACSLyric 2L6C Instrument (BD) – power supply module issue (2024)

On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.

Moderate

FDANov 1, 2024Nationwide• Becton, Dickinson and Company, BD Bio Sciences

FACSLyric 3L12C Instrument (BD) – power supply module issue (2024)

On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.

Moderate

FDANov 1, 2024Nationwide• Becton, Dickinson and Company, BD Bio Sciences

FACSLyric 3L8C Instrument (BD) – power supply module issue (2024)

On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.

Moderate

FDANov 1, 2024Nationwide• Becton, Dickinson and Company, BD Bio Sciences

FACSLyric 2L4C Instrument (BD) – power supply module issue (2024)

On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users

FDANov 1, 2024Nationwide• Becton, Dickinson and Company, BD Bio Sciences

BD FACSDuet Preparation System (BD) - Sample Dispensing Error (2024)

Sample preparation system with software may cause: 1) Multidispense feature enabled with 2-tube assay: Specimen volume dispensed into tube1 at least 3% higher than volume in tube2, or 2) Absolute counts calculated using Trucount Tubes: increased volume in tube1 may result in 20% higher absolute counts in tube 1 than tube 2; could result in additional blood collection, delayed results/patient therapy.

FDAAug 12, 2024AK, CA, ID +10 more• Becton, Dickinson and Company, BD Bio Sciences

Becton, Dickinson and Company, BD Biosciences: BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multite...

Multitest with compromised raw material used to assess immune system status may result in flow cytometry plot with unusual staining pattern, nonspecific aggregates, high background, double positive event increase on CD3+CD4+vsCD3+CD8+ and/or CD3-CD16+CD56+vsCD3-CD19+, contaminated antibodies, may lead to erroneous or delayed results, additional patient sample, might impact healthcare decisions

FDAMay 8, 2024AL, AR, CA +31 more• Becton, Dickinson and Company, BD Biosciences

Becton, Dickinson and Company, BD Biosciences: CD11b APC: ASR, REF: 340936, and CE, REF: 333143

In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false negative results and misdiagnosis of hematological malignancy, delayed treatment, and the need for additional patient samples.

FDAOct 25, 2023Nationwide• Becton, Dickinson and Company, BD Biosciences

Becton, Dickinson and Company, BD Biosciences: BD Multitest 6-Color TBNK with optional BD Trucount Tubes...

Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant.

Moderate

FDAOct 3, 2022AL, AZ, AR +40 more• Becton, Dickinson and Company, BD Biosciences

Becton, Dickinson and Company, BD Biosciences: BD Trucount Tubes (Cat. No. 663028), used for determining...

Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant. Firm root cause investigation confirmed that label detachment is due to an adhesive change by a tier 2 supplier.

Moderate

FDAOct 3, 2022AL, AZ, AR +40 more• Becton, Dickinson and Company, BD Biosciences

Becton, Dickinson and Company, BD Biosciences: BD Trucount Tubes (Cat. No. 340334), used for determining...

Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant. Firm root cause investigation confirmed that label detachment is due to an adhesive change by a tier 2 supplier.

Moderate

FDAOct 3, 2022AL, AZ, AR +40 more• Becton, Dickinson and Company, BD Biosciences

Becton, Dickinson and Company, BD Biosciences: BD Anti-Kappa APC (Cat. No. 341098) is an analyte specifi...

Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.

Moderate

FDAMar 25, 2022Nationwide• Becton, Dickinson and Company, BD Biosciences

Becton, Dickinson and Company, BD Biosciences: BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific...

Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.

Moderate

FDAMar 25, 2022Nationwide• Becton, Dickinson and Company, BD Biosciences

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Becton, Dickinson and Company, BD Bio Sciences Recalls

Recall Summary

BD Trucount Controls (BD Bio Sciences) – Incorrect SD Values (2025)

BD FACS Setup Beads (Becton Dickinson) – Spectral Overlap Error (2025)

BD FACS Setup Beads (Becton Dickinson) – Spectral Overlap Error (2025)

FACSLyric 3L10C Instrument (BD) – power supply module issue (2024)

FACSLyric 2L6C Instrument (BD) – power supply module issue (2024)

FACSLyric 3L12C Instrument (BD) – power supply module issue (2024)

FACSLyric 3L8C Instrument (BD) – power supply module issue (2024)

FACSLyric 2L4C Instrument (BD) – power supply module issue (2024)

BD FACSDuet Preparation System (BD) - Sample Dispensing Error (2024)

Becton, Dickinson and Company, BD Biosciences: BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multite...

Becton, Dickinson and Company, BD Biosciences: CD11b APC: ASR, REF: 340936, and CE, REF: 333143

Becton, Dickinson and Company, BD Biosciences: BD Multitest 6-Color TBNK with optional BD Trucount Tubes...

Becton, Dickinson and Company, BD Biosciences: BD Trucount Tubes (Cat. No. 663028), used for determining...

Becton, Dickinson and Company, BD Biosciences: BD Trucount Tubes (Cat. No. 340334), used for determining...

Becton, Dickinson and Company, BD Biosciences: BD Anti-Kappa APC (Cat. No. 341098) is an analyte specifi...

Becton, Dickinson and Company, BD Biosciences: BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific...