Z-0969-2018 Class III Terminated
FDA device recall Z-0969-2018 was initiated by Randox Laboratories on August 11, 2017 and is designated Class III. 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. The recall status is terminated (terminated March 29, 2019). Affected quantity: 117 Kits.
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
- 117 Kits
Product Description
Immunoassay Premium 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: IA2633 (Lots: 398703, 402366) IA2638 (Lot 1666EC) IA2639 (Lots: 1486EC, 1516EC, 1626EC) IA2640 (Lots 1517EC, 1668EC)