Recall Z-1106-2019 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Randox Laboratories Ltd.
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
| Date | Feb 7, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Employee error |
| 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. |
| Quantity | 12 |
| Distribution | The products were distributed to the following US states: WV and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140522 | RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL Randox Laboratories Limited, May 22, 2014 |