FDAClass IISeptember 9, 2020

Amylase AY3805 batch 480449 Amylase Ethylidene recall

Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent

Why was Amylase AY3805 batch 480449 Amylase Ethylidene recalled?

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 should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

AY3805 GTIN 05055273200607

Product
Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
Recalling firm
RANDOX LABORATORIES, LTD.
Quantity
1497 units
Distribution
New Mexico, Massachusetts, WV. Foreign distribution to Bolivia BOSNIA AND HERZEGOVINA Brazil Colombia Costa Rica Cyprus Egypt France Greece Grenada India Iraq Italy Jordan Kazakhstan Kenya Lithuania Mauritius Nepal Nigeria Pakistan Peru Philippines Poland Portugal Qatar Romania Russia South Africa Thailand The Bahamas Turkey UAE UK Vietnam
Recall date
September 9, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls