BD Trucount Controls (BD Bio Sciences) – Incorrect SD Values (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
Brand
Becton, Dickinson and Company, BD Bio Sciences
Lot Codes / Batch Numbers
Lot: 4285713/UDI: 00382906643438
Products Sold
Lot: 4285713/UDI: 00382906643438
Becton, Dickinson and Company, BD Bio Sciences is recalling BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD due to Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead co. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
Recommended Action
Per FDA guidance
On July 8, 2025, BD Biosciences issued a "Urgent: Medical Device Recall Correction" via mail. BD ask consignees to take the following actions: 1. Ensure the contents of this product notification are read and understood. 2. Share and post this customer letter with the users of this application at your facility and forward to any customers to whom you may have distributed the product to ensure awareness. 3. It is recommended that this notice be posted where these products are stored. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted product, so that BD may acknowledge your receipt of this notification. 5. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026