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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

VITROS Chemistry CRP Slides Recalled for Incorrect Labeling

Agency Publication Date: May 29, 2025
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Summary

Ortho-Clinical Diagnostics, Inc. has recalled 3,587 units of VITROS Chemistry Products CRP Slides because they were labeled with the incorrect generation number. The product packaging, foil wrappers, and cartridge labels incorrectly identify the slides as Generation 88 (GEN 88) when they are actually Generation 83 (GEN 83). No incidents or injuries related to this labeling error have been reported.

Risk

The use of incorrectly labeled diagnostic slides can lead to improper instrument calibration or the misinterpretation of test results. This could potentially result in incorrect medical diagnoses or treatment decisions for patients.

What You Should Do

  1. This recall involves VITROS Chemistry Products CRP Slides (Catalog 8097990, GTIN 10758750004355) with Coating Number 1291. Each sales unit contains 5 cartridges of 18 slides each.
  2. Check the lot numbers printed on your product carton, foil wrapper, or cartridge label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product immediately.
  4. Contact Ortho-Clinical Diagnostics, Inc. or your authorized medical distributor to arrange for a return, replacement, or correction of the affected product.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: VITROS Chemistry Products CRP Slides
Variants: 90 Slides per unit (5 cartridges of 18 slides)
Model / REF:
8097990
Lot Numbers:
3788-1291-0019
3788-1291-0052
3788-1291-0078
3788-1291-0079
3788-1291-0080
3788-1291-9975
GTIN:
10758750004355

Coating Number: 1291. Incorrectly assigned GEN 88 instead of GEN 83.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96784
Status: Active
Manufacturer: Ortho-Clinical Diagnostics, Inc.
Sold By: Authorized medical distributors
Manufactured In: United States
Units Affected: 3,587 units
Distributed To: Arkansas, Arizona, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Michigan, Minnesota, Missouri, Mississippi, Montana, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Wisconsin, West Virginia, Wyoming

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.