IgE Calibrator Series — Class II medical device recall Z-0050-2017
Terminated recall by Randox Laboratories Ltd., reported 2016-10-12. According to the firm, the IgE Calibrator Series IE2492 (lot 387-392IE) value assignment has now been aligned
| Recall number | Z-0050-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), N/A, Ireland |
| Recall initiated | 2016-09-07 |
| Classified | 2016-10-06 |
| Reported by FDA | 2016-10-12 |
| Terminated | 2017-09-07 |
| Quantity | 4 |
| Lot numbers | 354213, 386994 |
| Model numbers | IE2492 |
Product
IgE Calibrator Series
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0050-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.