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Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc. Recalls

All product recalls associated with Ortho-Clinical Diagnostics, Inc..

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Recall Summary

Total Recalls

475

Past Year

Class I (Serious)

Most Recent

Nov 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 121–140 of 475 recalls

VITROS Chemistry Calibrator Kit (Ortho-Clinical) - Calibration Problem (2023)

Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing

FDAApr 14, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

Atellica CH Toxicology Calibrator (Siemens) – Calibration Reassignment (2023)

Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias

FDAApr 5, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

ADVIA Chemistry ToxAmmonia Calibrator (Siemens) – Calibration Reassignment (2023)

Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias

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Page 7 of 24Next

FDA

Apr 5, 2023

Nationwide

• Siemens Healthcare Diagnostics, Inc.

Immundiagnostik IDK Lactoferrin ELISA (IMMUNDIAGNOSTIK) – no 510k (2023)

Marketed without a 510k

FDAMar 27, 2023Nationwide• IMMUNDIAGNOSTIK, Inc

STA Compact Analyzer (Diagnostica Stago) – coagulation time issue (2023)

An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13).

FDAMar 22, 2023Nationwide• Diagnostica Stago, Inc.

STA Compact Max Analyzer (Diagnostica Stago) – coagulation time issue (2023)

FDAMar 22, 2023Nationwide• Diagnostica Stago, Inc.

STA R Max Instrument (Diagnostica Stago) – coagulation time issue (2023)

FDAMar 22, 2023Nationwide• Diagnostica Stago, Inc.

ADVIA Centaur Cortisol Test (Siemens) – urine sample bias (2023)

There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.

FDAMar 16, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica IM Cortisol Test (Siemens) – urine sample bias (2023)

There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.

FDAMar 16, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

VITROS 5600 Integrated System (Ortho-Clinical Diagnostics) – MicroTip Pack Issue (2023)

MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable

FDAMar 10, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

VITROS XT 7600 Integrated System (Ortho-Clinical Diagnostics) – MicroTip Pack Issue (2023)

MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable

FDAMar 10, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

VITROS Anti-SARSCoV-2 Antibody Calibrators (Ortho-Clinical) – Calibration Levels (2023)

Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD), resulting in delayed patients results

FDAMar 9, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

Dimension Tacrolimus Flex (Siemens) – Imprecision Issue (2023)

Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Control (QC) and patient samples with Dimension Tacrolimus (TAC) lots GA2286, GA3047 and GA3171. The health consequences of erroneous patient results are major, since in a worst case scenario, a patient s tacrolimus dosing could be altered, resulting in potential organ failure and rejection (due to too low or no tacrolimus being administered) or toxicity (due to too much tacrolimus being administered). Siemens internal investigation of the Dimension TAC assay showed the worst case imprecision with patient samples at the low end of the Analytical Measurement Range (AMR). A patient sample at 2.0 ng/mL (2.6 nmol/L) recovered as 0.0 ng/mL (0.0 nmol/L) (100% negative bias), another patient sample at 2.1 ng/mL (2.7 nmol/L) recovered at 4.3 ng/mL (5.6 nmol/L) (103% positive bias).

FDAJan 30, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica CH Triglycerides_2 (Siemens) – Reagent Carryover (2023)

Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results

FDAJan 27, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica CH Triglycerides (Siemens) – Reagent Carryover (2023)

Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results

FDAJan 27, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica CH Total Protein II (Siemens) – Reagent Carryover (2023)

Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results

FDAJan 27, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica CH LDL Cholesterol (Siemens) – Reagent Carryover (2023)

Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results

FDAJan 27, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica IM Folate 140 Test Kit (Siemens) – Calibration Bias (2023)

Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.

FDAJan 9, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

ADVIA Centaur Folate 500 Test Kit (Siemens) – Calibration Bias (2023)

Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.

FDAJan 9, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

ADVIA Centaur Folate 100 Test Kit (Siemens) – Calibration Bias (2023)

Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.

FDAJan 9, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.