Recall Z-2167-2017 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Randox Laboratories
Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems.
| Date | May 26, 2017 (initiated Apr 27, 2017) |
| Status | Terminated |
| Reason | According to Randox Laboratories an investigation indicates a labelling error for 2 of the test methods listed for quantification of Total Protein (urine). The values for the mean of all instruments are incorrect by a factor of 10. Instrument specific values are correct. This does not affect the performance or stability claims of the product. As control results will be outside of the quoted range this may result in a delay in reporting the sample test results. However as the correct instrument specific means are also included in the value sheet this delay is unlikely. Customers have been re |
| Root cause | Error in labeling |
| Action | Randox Laboratories will contact Customers directly by e-mail and will be followed up with once every 2 weeks over a period of 6 weeks. There are no plans in place to follow up with customers after the 6 week period. For further questions, please call (304) 728-2890. |
| Quantity | 198 kits |
| Distribution | Worldwide Distribution - US Distribution to Puerto Rico and to the countries of : Canada Kuwait Chile Poland China Romania France Saudi Arabia Guatemala Slovenia Iran UAE India UK Italy Uruguay Iraq |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110904 | RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3 Randox Laboratories, Ltd., Sep 30, 2011 |