Ortho-Clinical VITROS CRP Slides Recall: Incorrect Gen Code May Cause Errors
Ortho-Clinical recalls VITROS CRP Slides with incorrect generation code (GEN 88 instead of GEN 83) that could lead to test errors. Affected units have specific lot numbers and catalog codes.
Lower-risk recall
Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.
Contact the company
What happened, in plain English
Ortho-Clinical is recalling VITROS Chemistry Products CRP Slides because one sales unit contains slides with an incorrect generation code (GEN 88 instead of GEN 83) on the packaging and labels. This could cause inaccurate test results if used in medical testing equipment. Read more at govinfonow.com/recall/52455-ortho-clinical-vitros-crp-slides-recall-incorrect-gen-code-may.
Source Summary by GovInfoNow · govinfonow.com/recall/52455-ortho-clinical-vitros-crp-slides-recall-incorrect-gen-code-may · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1876-2025
Cite this page
“Ortho-Clinical VITROS CRP Slides Recall: Incorrect Gen Code May Cause Errors.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52455-ortho-clinical-vitros-crp-slides-recall-incorrect-gen-code-may. Based on FDA recall #Z-1876-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1876-2025%22&limit=1).
Why it’s dangerous
The slides have the wrong generation code (GEN 88 instead of GEN 83) on the product carton, foil wrapper, and cartridge labels. This could lead to inaccurate test results when used in medical diagnostic equipment.
Who’s affected
Healthcare facilities using these slides for medical testing are likely affected. The risk is low as the error only affects test accuracy, not safety.
How to tell if you have this one
Check for the catalog number 8097990 and lot numbers: 3788-1291-0019, 3788-1291-0052, 3788-1291-0078, 3788-1291-0079, 3788-1291-0080, or 3788-1291-9975.
- Brand
Ortho-Clinical- Product
VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of- Category
Medical device
What to do — step by step
Check Product Labels
Look for the catalog number 8097990 and lot numbers listed above on the slides or packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 29 states.
FDA distribution: “Worldwide - US Nationwide distribution in the states of AR, AZ, CO, FL, GA, ID, IL, IN, KS, MI, MN, MO, MS, MT, ND, NE, NH, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WI, WV & WY and the countries of Canada, Chile, Colombia, France, India, Italy,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Arkansas, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New York, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 51 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using these slides?
No action is required for the product itself, but you should check the labels to ensure you have the correct generation code for accurate test results.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1876-2025 (April 14, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1876-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.