Z-2923-2020 Class II Terminated
FDA device recall Z-2923-2020 was initiated by RANDOX LABORATORIES, LTD. on July 10, 2020 and is designated Class II. 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. The recall status is terminated (terminated June 17, 2021). Affected quantity: 1497 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 9, 2020
- Initiation Date
- July 10, 2020
- Termination Date
- June 17, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1497 units
Product Description
Reason for Recall
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