Randox recalls AM1054 ammonia reagents due to potential overestimation of ammonia levels in patient samples. Affected units may cause inaccurate test results.
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 AM1054 ammonia reagents because they can overestimate ammonia levels in patient samples by up to 140 mol/l. This could lead to incorrect test results, which might affect diagnosis and treatment decisions.
The reagents show a positive bias, meaning they measure ammonia levels 140 mol/l higher than actual. This overestimation could lead to false high readings in patient samples, potentially causing misdiagnosis or inappropriate treatment.
Lab users who purchased the AM1054 reagents for ammonia testing in plasma. Patients relying on these tests for accurate ammonia levels may be at risk of incorrect results.
Check for the product name 'AM1054 Randox Ammonia (NH3), Enzymatic UV Method' with lot number 512103 and batch 512103. The GTIN is 05055273200263.
Verify the lot number and batch number on the reagent label to confirm if it's affected.
The reagents show a positive bias of up to 140 mol/l, which could lead to inaccurate ammonia test results in patient samples.
The recall record does not specify a remedy, so check the reagent details to confirm if it's affected and contact Randox for further guidance.
The recall is for potential inaccurate test results, not direct health risks. However, incorrect ammonia levels could affect diagnosis and treatment.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-2966-2020 — Randox Randox Hello, I own a Randox that is covered by recall Z-2966-2020 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.
