FDA Device

Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent

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 You Should Do

Remedy

The consumers were sent a letter via email dated July 10, 2020. This notice instructs customers to The distributors and customers will be instructed to: -Discontinue use of batches listed above immediately -Review your reagent inventory of these products and assess your laboratories needs for replacements. Proof of remaining kits will be required. -Discuss the contents of this notice with your Medical Director. -Complete and return the response form

Products

Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
Brand
RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom
UPC
AY3805 GTIN 05055273200607

Units Affected

1497 units