FDA Device recall Z-0050-2017
IgE Calibrator Series
- FDA Device
- Class II
- terminated
- Published 2016-10-12
On 2016-10-12 the FDA classified a Class II recall of IgE Calibrator Series by Randox Laboratories, citing 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. Turbidi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0050-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-09-07 |
| Published | 2016-10-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Randox Laboratories |
| Distribution | n/a |
Product
IgE Calibrator Series
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.
Identifiers
| code_info | Catalogue number IE2492 Batch number 354213, 386994 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0050-2017%22
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