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Recall Observatory FDA recall evidence

Device product

IgE Calibrator Series

Z-0050-2017

September 07, 2016

Class II

Product summary

Firm
Randox Laboratories Ltd.
Event
Event 75208
Status
Terminated
Classification
Class II
Quantity
4
Official record key
device-enforcement:Z-0050-2017

Official wording

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.

Code information: Catalogue number IE2492 Batch number 354213, 386994

Distribution pattern: All consignees are in the US.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.