Recall Z-0050-2017 ยท DGC Ige, Antigen, Antiserum, Control
Randox Laboratories Ltd.
IgE Calibrator Series
| Date | Oct 6, 2016 (initiated Sep 7, 2016) |
| Status | Terminated |
| Reason | According to the firm, the IgE Calibrator Series IE2492 (lot 387-392IE) value assignment has now been aligned to the 3rd International Standard for human serum IgE 11/234. Turbidimetric (Non-IFCC Cal.) Quality Control Targets and Ranges now apply. The calibrator value sheet is to be updated with the new values. |
| Root cause | Under Investigation by firm |
| Action | The firm plans on contacting each consignee about the recall. |
| Quantity | 4 |
| Distribution | All consignees are in the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010855 | RANDOX IGE Randox Laboratories, Ltd., May 15, 2001 |