FDA Device

IgE Calibrator Series

Hazard

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.

What You Should Do

Remedy

The firm plans on contacting each consignee about the recall.

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Products

IgE Calibrator Series
Brand
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
UPC
Catalogue number  IE2492  Batch number  354213, 386994

Units Affected

4

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