Z-2965-2020 Class II Terminated
FDA device recall Z-2965-2020 was initiated by RANDOX LABORATORIES, LTD. on July 30, 2020 and is designated Class II. Reason for recall: Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples. The recall status is terminated (terminated February 3, 2021). Affected quantity: 143 kits in total.
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2020
- Initiation Date
- July 30, 2020
- Termination Date
- February 3, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 143 kits in total
Product Description
AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
Reason for Recall
Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples.
Distribution Pattern
US Distribution to states of: VA, UT, WV and country of : Canada
Code Information
Catalogue Number: AM1015 GTIN: 05022273200256 Lot #: 517541 batch 517541