Recall Z-0050-2017
Randox Laboratories Ltd. · initiated September 7, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
IgE Calibrator Series
Codes / lots: Catalogue number IE2492 Batch number 354213, 386994
Reason for recall
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.
FDA-determined cause: Under Investigation by firm
Action taken
The firm plans on contacting each consignee about the recall.
Details
- Recall number
- Z-0050-2017
- Initiated
- September 7, 2016
- Posted by FDA
- October 6, 2016
- Terminated
- September 7, 2017
- Product code
- DGC – Ige, Antigen, Antiserum, Control
- Quantity
- 4
- Distribution
- All consignees are in the US.
- Recalling firm
- Randox Laboratories Ltd., Crumlin, North