Z-0970-2018 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 21, 2018
- Initiation Date
- August 11, 2017
- Termination Date
- March 29, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 199 Kits
Product Description
Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
Reason for Recall
The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.
Distribution Pattern
Distribution US nationwide.
Code Information
Catalog numbers: IA3109 (Lots: 1476EC, 1573EC, 1619EC) IA3110 (Lots 1477EDC, 1599EDC, 1621EC, 1662EC) IA3111 (Lots: 1478EC, 1508EC, 1578EC, 1647EC) IA3112 (Lots: 359199, 377412, 373302, 382147, 382679, 395668, 416979)