Ortho Clinical Diagnostics recalls VITROS CKMB Slides that may cause falsely elevated results due to CK-MM interference. Affected products include 60-slide and 18-slide cartridges with specific product codes and lot numbers.
VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference
Ortho Clinical Diagnostics is recalling VITROS CKMB Slides that can cause false high results in blood tests due to interference with CK-MM. This affects specific slide cartridges sold with certain product codes and lot numbers. Users should check their product details to see if they are affected.
The slides may produce false high readings for creatine kinase MB (CK-MB) in blood tests due to interference from CK-MM. This could lead to incorrect health assessments if the test results are used for diagnosis.
Lab users who test blood with VITROS CKMB Slides may be affected. Those using the specific 60-slide and 18-slide cartridges with product codes 8058232 and 8001133 are most at risk.
Check for product codes 8058232 (60-slide cartridge) or 8001133 (18-slide cartridge). Also look for lot numbers 0230, 0231, 0233, 0235, 0239, 0245, 0246, 0248, or 0261.
Identify your VITROS CKMB Slides by product code (8058232 or 8001133) and lot number (0230, 0231, 0233, 0235, 0239, 0245, 0246, 0248, or 0261).
The VITROS CKMB Slides may cause falsely elevated results due to interference with CK-MM, which could lead to incorrect health assessments.
Affected products include VITROS CKMB Slides (60-slide cartridge with product code 8058232) and (18-slide cartridge with product code 8001133), with specific lot numbers.
No, the recall does not require stopping use immediately. Affected users should check their product details to confirm if they are affected.
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-0770-2021 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-0770-2021 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.
