Medium RiskFDA Device

RANDOX LABORATORIES, LTD.: 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.

Agency Publication Date: August 29, 2020

Affected Products

Product: Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent

AY3805 GTIN 05055273200607

Product: Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent

AY3855 GTIN 05055273200614

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86114

Status: Resolved

Manufacturer: RANDOX LABORATORIES, LTD.

Manufactured In: United Kingdom

Units Affected: 2 products (1497 units; 105 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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