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.
Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.
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.
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.
Healthcare facilities using these slides for medical testing are likely affected. The risk is low as the error only affects test accuracy, not safety.
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.
Look for the catalog number 8097990 and lot numbers listed above on the slides or packaging.
The product was incorrectly labeled with GEN 88 instead of GEN 83 on the carton, foil wrapper, and cartridge labels, which could cause inaccurate test results.
Check for 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.
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.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-1876-2025 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1876-2025 from Ortho-Clinical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
