Z-1106-2019 Class III Terminated
FDA device recall Z-1106-2019 was initiated by Randox Laboratories Ltd. on February 7, 2019 and is designated Class III. Reason for recall: The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U. The recall status is terminated (terminated June 8, 2020). Affected quantity: 12.
Recall Details
- Product Type
- Devices
- Report Date
- April 17, 2019
- Initiation Date
- February 7, 2019
- Termination Date
- June 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12
Product Description
Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
Reason for Recall
The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.
Distribution Pattern
The products were distributed to the following US states: WV and Puerto Rico.
Code Information
Lot codes: 1714EC 430312 432364