Ortho-Clinical Diagnostics recalls VITROS CKMB Slides (Product Code 805 8232-300) due to false plasma test results from Spanish/Swedish IFU 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 (Product Code 805 8232-300) because the Spanish and Swedish language instructions incorrectly state that plasma can be used for testing. This could lead to inaccurate test results for heart attacks.
The Spanish and Swedish language versions of the instructions incorrectly state that plasma can be used for testing. This could lead to inaccurate results for creatine kinase MB (CK-MB) tests, which are used to detect heart attacks. Using the slides with plasma instead of serum may cause false positive or negative results.
Lab users who purchased the VITROS CKMB Slides (Product Code 805 8232-300) with UDI Number 10758750004294, especially those using the Spanish or Swedish language versions of the instructions. Patients undergoing cardiac tests may be at risk of inaccurate results.
Check for the Product Code 805 8232-300 on the slides. The UDI Number 10758750004294 is specific to the affected units. These slides expire after July 20, 2018.
Verify if your slides have Spanish or Swedish language instructions, as these versions contain incorrect testing instructions.
Ensure the slides expire after July 20, 2018, as older units are affected.
The Spanish and Swedish language versions of the instructions incorrectly state that plasma can be used for testing, which could lead to inaccurate results for heart attack tests.
No, but you should check if your slides have Spanish or Swedish instructions and verify the expiry date. If they do, contact Ortho-Clinical Diagnostics for guidance.
Check the language of your instructions and expiry date. If they match the affected units, contact Ortho-Clinical Diagnostics for instructions on how to proceed.
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-1930-2020 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-1930-2020 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.
