Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

IgE Calibrator Series

FDA Recall Z-0050-2017 · Posted 2016-10-06

Recalling FirmRandox Laboratories Ltd.
Recall StatusTerminated
Product CodeDGC
Date Initiated2016-09-07
Date Terminated2017-09-07
Product Quantity4

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.

Firm Action

The firm plans on contacting each consignee about the recall.

Root Cause

Under Investigation by firm

Distribution Pattern

All consignees are in the US.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010855RANDOX IGERandox Laboratories, Ltd. · 2001-05-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑