Device product
Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
Z-0969-2018
Product summary
- Event
- Event 79076
- Status
- Terminated
- Classification
- Class III
- Quantity
- 117 Kits
- Official record key
device-enforcement:Z-0969-2018
Official wording
Reason: The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.
Code information: Catalog numbers: IA2633 (Lots: 398703, 402366) IA2638 (Lot 1666EC) IA2639 (Lots: 1486EC, 1516EC, 1626EC) IA2640 (Lots 1517EC, 1668EC)
Distribution pattern: Distribution US nationwide.
Derived failure modes
-
Unknown
The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.