IgE Calibrator Series
This recall has been terminated (originally issued October 6, 2016).
- Recall Initiated
- September 7, 2016
- Posted
- October 6, 2016
- Terminated
- September 7, 2017
- Recall Number
- Z-0050-2017
- Quantity
- 4
- Official Source
- View on FDA website ↗
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.
Distribution
All consignees are in the US.
Lot / Code Info
Catalogue number IE2492 Batch number 354213, 386994
Root Cause
Under Investigation by firm
Action Taken
The firm plans on contacting each consignee about the recall.
More recalls by Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C...
Jul 24, 2024
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination
of parent...
May 9, 2024
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based...
May 3, 2024