Device product
Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
Z-2923-2020
Product summary
- Event
- Event 86114
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1497 units
- Official record key
device-enforcement:Z-2923-2020
Official wording
Reason: 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.
Code information: AY3805 GTIN 05055273200607
Distribution pattern: 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
Derived failure modes
-
Unknown
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.