Ortho-Clinical Diagnostics recalls VITROS CKMB Slides (Product Code 8001133-90) due to false plasma test results in Spanish/Swedish language versions of instructions. Affected units expire after July 20, 2018.
The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results.
Ortho-Clinical Diagnostics is recalling VITROS CKMB Slides that may give false test results when used with plasma in Spanish or Swedish language versions of the instructions. This could lead to inaccurate heart attack detection.
The Spanish and Swedish language versions of the instructions incorrectly state that plasma can be used for testing. This leads to biased results, potentially causing false positive or negative heart attack diagnoses.
Lab users who purchased the VITROS CKMB Slides (Product Code 8001133-90) with Spanish or Swedish language instructions. Those testing plasma samples could face inaccurate results.
Check for Spanish or Swedish language instructions with Product Code 8001133-90. The slides expire after July 20, 2018 or within current expiry dates.
Look for Spanish or Swedish language versions of the instructions on the product packaging.
Confirm the product code is 8001133-90 on the packaging.
The Spanish and Swedish language versions of the instructions incorrectly state that plasma can be used for testing, which could lead to biased results.
No, but you should check if your instructions are in Spanish or Swedish and verify the product code.
Using these slides with plasma in Spanish or Swedish language instructions could cause inaccurate heart attack test results.
We’ve drafted a message you can send Ortho-Clinical Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1931-2020 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-1931-2020 from Ortho-Clinical Diagnostics. 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.
