FDA Recall
Terminated
IgE Calibrator Series
Recall: Z-0050-2017
·
Initiated September 7, 2016
Recall
- Recall Number
- Z-0050-2017
- Event Number
- 75208
- Firm
- Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
- FEI Number
- 1000361607
- Product Code
- DGC
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- September 7, 2016
- Posted
- October 6, 2016
- Terminated
- September 7, 2017
Description
IgE Calibrator Series
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.
Action
The firm plans on contacting each consignee about the recall.
Distribution
All consignees are in the US.
Quantity
4