Stay Informed

Get email alerts when new recalls match your interests.

Recall data is updated hourly from official government sources. Very recent recalls may not yet appear. About our data sources

About

We make U.S. recall data searchable and accessible for consumers and businesses.

Site

FAQ
Browse by State
Statistics
Recall Classifications
About
Enterprise API

Legal

Privacy Policy
Terms of Service
Report Incorrect Info

Official Sources

FDA Recalls ↗
USDA FSIS ↗
CPSC Recalls ↗
NHTSA Recalls ↗

RSS Feed

Home
/
Brands
/
Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc. Recalls

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

Get alerts for this brand

Recall Summary

Total Recalls

1000

Past Year

303

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 1321–1340 of 4747 recalls

Ortho-Clinical Diagnostics, Inc.: VITROS Chemistry Products VersaTips - Product Usage: used...

A deformity affecting a specific lot of VITROS Chemistry Products VersaTips. Deformed VersaTips results may be biased by up to +/-16% for both immunometric and competitive assays.

FDAJan 14, 2021Nationwide• Ortho-Clinical Diagnostics, Inc.

Testosterone Cypionate Injection (Sun Pharma) – Incorrect Labeling (2021)

Incorrect Labeling: Incorrect lot number on secondary packaging

Class IIILow

FDAJan 11, 2021Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Cairn Diagnostics: 13C-Spirulina Gastric Emptying Breath Test (GEBT) - Produ...

Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates

1...65 666768 69...238

Page 67 of 238Next

FDAJan 8, 2021Nationwide• Cairn Diagnostics

Nortriptyline HCl Capsules (Taro) – CGMP Deviation (2021)

CGMP deviations.

Class IIModerate

FDAJan 8, 2021Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Roche Diagnostics Operations, Inc.: 9180 Electrolyte Analyzer - Product Usage: intended to be...

May display Calcium results on the screen with wrong arrow direction which may lead to misinterpretation of results and incorrect medical decision. If the unit for iCa++ is set to mg/dL (configured as Service Code MGL) and a measured iCa++ value is lower than the normal range, an upward arrow is shown on the display instead of a downward arrow. The display is set per default to mmol/L; therefore, the arrow indicating an alarm reflects normal ranges of iCa++ in mmol/L. If mg/dL is chosen, the arrow warnings on screen still reflect the ranges from mmol/L, rather than mg/dL. The numeric result is displayed correctly.

FDAJan 6, 2021Nationwide• Roche Diagnostics Operations, Inc.

Getinge Group Logistics America, LLC: Getinge CM320 Series Washer Disinfector - Product Usage: ...

Fire/Burn Risk

The potential that the plastic inlet hose connections may deform or break as a result of material fatigue and/or over tightening of the clamps. A broken hose connection may lead to a hazardous situation of water leakage or water spray. The water leakage or water spray may result in a burn to the user and/or an inconvenience due to a procedural delay if the Washer Disinfector is taken out of service.

FDADec 21, 2020Nationwide• Getinge Group Logistics America, LLC

Hardy Diagnostics: Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no:...

Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.

FDADec 21, 2020AZ, CA, CT +8 more• Hardy Diagnostics

Roche Diagnostics Operations, Inc.: A calculator/data processing module for clinical use is a...

A software error results in the unintentional removal of the serum-indices flag that would otherwise prevent the release of results. The Cobas Inifinity has an auto-verification feature to hold results for manual review when they meet specific criteria. The serum indices flag is used for serum indices tests that are performed to assess the quality of the sample (e.g. hemolysis, icterus, and lipemia). Normally, when the Cobas Infinity receives a result for a test that is serum indices-sensitive, it flags the result and the software then waits for the results of the serum indices tests before validating or rejecting the test result. Roche has discovered a software error that under specific conditions causes the flag to be incorrectly removed. This allows for the possibility that a sample of poor quality may return an unreliable/incorrect test result that is mistakenly reported to the health care provider and/or patient without the proper disclaimer that the result is based on a sample of poor quality.

FDADec 17, 2020Nationwide• Roche Diagnostics Operations, Inc.