Randox recalls specific batches of Amylase Ethylidene Blocked-pNPG7 Reagent due to performance failures before expiry. Affected units may not function correctly as intended.
Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on 28th Sept 2020.
Randox is recalling certain batches of Amylase Ethylidene Blocked-pNPG7 Reagent because they failed to meet performance standards before their Sept 2020 expiry date. This means the reagent might not work properly in lab tests.
The reagent failed to meet performance claims before its expiry date, meaning it might not function correctly in laboratory tests. This could lead to inaccurate test results if used without proper validation.
Lab users who purchased the specific batch numbers (AY3805 batch 480449 or AY3855 batch 480483) before September 28, 2020, are affected. Those using the reagent for medical testing are most at risk.
Check for the batch numbers: AY3805 batch 480449 or AY3855 batch 480483. The product is sold under the GTIN 05055273200607.
Look for the batch numbers AY3805 480449 or AY3855 480483 on the product label.
The reagent failed to meet performance claims before its expiry date of September 28, 2020.
The recall record does not specify a remedy, so no action is required beyond checking the batch number.
The reagent may not function correctly in lab tests, so it should be checked for performance issues before use.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-2923-2020 — Randox Randox Hello, I own a Randox that is covered by recall Z-2923-2020 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.
