Product Wiki · Recalls · U.S. FDA — Device Enforcement

Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent — recall Z-2923-2020

U.S. FDA — Device Enforcement · United Kingdom · 2020-07-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2923-2020
Date of alert
2020-07-10
Country / jurisdiction
United Kingdom
Risk level
Class II
Risk type
recall
Brand
RANDOX LABORATORIES, LTD.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05055273200607
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.