FDA Enforcement
Class II
Terminated
Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent
Recall: Z-2924-2020
·
Reported September 9, 2020
Enforcement
- Recall Number
- Z-2924-2020
- Event ID
- 86114
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- RANDOX LABORATORIES, LTD.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 9, 2020
- Initiation Date
- July 10, 2020
- Classification Date
- August 28, 2020
- Termination Date
- June 17, 2021
- Address
- 34 Diamond Rd, N/A, Crumlin Colorado Antrim, N/A, N/A, United Kingdom
Description
Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent
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 Info
AY3855 GTIN 05055273200614
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
105 units