Ortho-Clinical Diagnostics recalls AMYL Slides Reagent (Product Code 8112724) due to imprecision in lab test results. Affected lots may cause inaccurate amylase measurements.
Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.
Ortho-Clinical Diagnostics is recalling AMYL Slides Reagent products that may show inaccurate lab test results. This could lead to incorrect amylase measurements in blood tests, which might affect diagnosis of certain health conditions.
The reagent coatings show imprecision when compared to expected results in lab testing. This means the test might not measure amylase levels correctly, potentially leading to incorrect health diagnoses.
Lab users who purchased the recalled AMYL Slides Reagent products for blood testing. Those using the products for amylase measurements in clinical labs are most at risk of inaccurate results.
Check for the product code 8112724 and lot numbers listed in the recall notice. The reagent is used for amylase testing in blood samples with specific lab equipment models.
Verify the product code and lot numbers against the list provided in the recall notice to confirm if your item is affected.
The reagent coatings show imprecision when compared to expected results in lab testing, which could lead to inaccurate amylase measurements.
Check the product code and lot numbers against the list provided in the recall notice to determine if your item is affected.
The recall notice does not specify a remedy or fix for this issue.
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-2365-2020 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-2365-2020 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.
