Randox recalls Pancreatic Amylase AY3855 batch 480483 due to failing to meet performance claims before its 2020 expiry date. Affected units may not function correctly in lab tests.
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 a specific batch of Pancreatic Amylase reagent because it didn't meet promised performance standards before its expiry date. This could lead to inaccurate lab test results if used.
The reagent failed to meet performance claims before its expiry date, meaning it might not work correctly in lab tests. This could cause inaccurate results if used in medical or research settings.
Lab users who purchased Pancreatic Amylase AY3855 batch 480483 before September 28, 2020, are affected. Researchers and medical professionals using this reagent for lab tests are most at risk.
Check for the product name 'Pancreatic Amylase AY3855' and batch number 480483. The reagent was sold before September 28, 2020, with a GTIN of 05055273200614.
Verify the batch number and expiry date on the reagent label to confirm if it matches the recalled batch.
The recall is due to performance issues, not safety hazards. The reagent may not work correctly in lab tests but does not pose a direct health risk.
Look for the product name 'Pancreatic Amylase AY3855' and batch number 480483 on the label. The reagent was sold before September 28, 2020.
The recall does not specify a remedy, so contact Randox Laboratories for guidance on handling the product.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-2924-2020 — Randox Randox Hello, I own a Randox that is covered by recall Z-2924-2020 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.