Ortho-Clinical Diagnostics recalls AMYL Slides Reagent (Product Code 1202670) 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 test results when compared to expected values in lab settings. This could lead to incorrect amylase measurements in blood tests, which are used to diagnose certain medical conditions.
The reagent coatings may produce imprecise results when compared to expected values in lab systems. This could lead to inaccurate amylase measurements in blood tests, potentially affecting diagnosis of certain medical conditions.
Lab users who have the specific AMYL Slides Reagent products listed in the recall (Product Code 1202670) are affected. Medical professionals and labs using these products for amylase testing are most at risk.
Check for Product Code 1202670 with lot numbers listed in the recall (e.g., 600203564949, 600203564950, etc.). These are used in lab testing for amylase activity in blood, urine, or plasma.
Look for lot numbers listed in the recall (e.g., 600203564949, 600203564950) on the reagent packaging.
The recalled product is Ortho-Clinical Diagnostics AMYL Slides Reagent (Product Code 1202670) used for amylase testing in labs.
Check the lot numbers on the reagent packaging; the recall lists specific lot numbers like 600203564949, 600203564950, etc.
The recall does not specify a remedy, so contact Ortho-Clinical Diagnostics directly for guidance on next steps.
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-2364-2020 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-2364-2020 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.
