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 Initiated
- February 7, 2019
- Terminated
- June 8, 2020
- Recall Number
- Z-1106-2019
- Quantity
- 12
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
The products were distributed to the following US states: WV and Puerto Rico.
Lot / Code Info
Lot codes: 1714EC 430312 432364
Root Cause
Employee error
Action Taken
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.
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