FDA Recall
Terminated
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
Recall: Z-1106-2019
·
Initiated February 7, 2019
Recall
- Recall Number
- Z-1106-2019
- Event Number
- 82184
- Firm
- Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
- FEI Number
- 1000361607
- Product Code
- JJY
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- February 7, 2019
- Terminated
- June 8, 2020
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
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.
Action
Urgent Medical Device Correction letters dated 2/7/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. For questions contact Randox Technical Services.
Distribution
The products were distributed to the following US states: WV and Puerto Rico.
Quantity
12