Recall Z-1255-2019 ยท JBL Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative
Randox Laboratories Ltd.
G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes
| Date | Apr 3, 2019 |
| Status | Terminated |
| Reason | The target values and ranges in these lots are incorrect. |
| Root cause | Nonconforming Material/Component |
| Action | Randox sent an Urgent Medical Device Correction notification letters dated 4/2/19 to affected customers. The letter identified the affected product, problem and action to be taken: " Discontinue use of and quarantine any of the above devices immediately. " Discuss the contents of this notice with your Medical Director. " Review results generated with the affected batches in line with the clinical profile of the patient. " Inform all relevant staff members. If you have supplied or transferred any potentially affected product to another facility or organization, let that facility know of the r |
| Quantity | 10 kits |
| Distribution | The products were distributed to the following US states: IL, OH, NC, PA, WI, WV and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.