Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
Check against the official notice below — it lists the full affected range.
Randox Laboratories, Ltd. is recalling Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 reagents because they failed to meet quoted performance claims before their expiration date of September 28, 2020. A total of 1,497 units were distributed across multiple locations, including New Mexico, Massachusetts, and West Virginia in the United States, as well as numerous countries internationally.
The record does not specify a remedy or what affected consumers should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. 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 Quantity: 1497 units Lot/code info: AY3805 GTIN 05055273200607
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.