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FDAJuly 10, 2020device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

randox laboratoriesrandox

UPCs

05055273200614

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent — Recall Details · AllClear