Recall Z-1107-2019
Randox Laboratories Ltd. · initiated February 7, 2019
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Liquid Immunoassay Premium Controls, Model Number LIA3105 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
Codes / lots: Lot codes: 1723EC
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.
FDA-determined 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.
Details
- Recall number
- Z-1107-2019
- Initiated
- February 7, 2019
- Terminated
- June 8, 2020
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Quantity
- 4
- Distribution
- The products were distributed to the following US states: WV and Puerto Rico.
- Recalling firm
- Randox Laboratories Ltd., Crumlin, North
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1105-2019 Class III | Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This…The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this… | 02/07/2019Terminated |
| Z-1106-2019 Class III | Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This…The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this… | 02/07/2019Terminated |