Randox recalls AM1015 Ammonia reagents due to potential positive bias in patient samples. This may lead to inaccurate ammonia levels in blood tests. Affected units include specific lot numbers.
Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples.
Randox is recalling its AM1015 Ammonia reagents because they can show up to 140 mol/l higher ammonia levels in patient samples than they should. This could lead to incorrect blood test results, which might affect diagnosis and treatment decisions.
The reagents can produce a positive bias of up to 140 mol/l in patient samples. This means test results might show higher ammonia levels than actually present, potentially leading to incorrect medical decisions.
Patients using Randox AM1015 Ammonia reagents for blood tests may be affected. Those with specific lot numbers (517541) are most at risk.
Check for the lot number 517541 on the reagent packaging. The product is sold under the catalog number AM1015 and GTIN 05022273200256.
Look for the lot number 517541 on the reagent packaging to confirm if it is affected.
The reagents can show up to 140 mol/l higher ammonia levels in patient samples than they should, which may lead to inaccurate test results.
The recall record does not specify a remedy, so check the lot number and contact Randox for further instructions.
The recall record does not mention any risk of serious injury; the hazard is limited to potential inaccurate test results.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-2965-2020 — Randox Randox Hello, I own a Randox that is covered by recall Z-2965-2020 from Randox. 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.
