Recall Z-1057-2019 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Randox Laboratories Ltd.
Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes: Calcium, Chloride, Glucose, Lactate, PCO2, pH, pO2, Potassium, Sodium and Total CO2.
| Date | Feb 13, 2019 |
| Status | Terminated |
| Reason | An error in the assignment of the control range pH in Blood Gas Control |
| Root cause | Process control |
| Action | The firm, Randox Laboratories Ltd, sent an "Urgent Medical Device Correction " letter dated 2/13/2019 to its customer on 2/13/2019 via email. The letter describes the product, problem and actions to be taken. The customer was instructed todo the following: " Please replace the amended value sheet within the kit of any remaining stock. " Discuss the contents of this notice with your Medical Director. " Randox Laboratories Ltd is not recommending a review of previous results as any issue would be observed at the time of use. " Please retain this letter with your laboratory re |
| Quantity | 1 kit |
| Distribution | US Distribution to state of: WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093384 | MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3) Diamond Diagnostics, Inc., Mar 10, 2010 |