Z-0050-2017Class II

IgE Calibrator Series

Name: Z-0050-2017 IgE Calibrator Series
Creator: Randox Laboratories Ltd.
Published: 2016-09-07
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2016-09-07 / Terminated / root cause: manufacturing process

FDA source

Randox Laboratories Ltd. began a recall of IgE Calibrator Series on 2016-09-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0050-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-07
Posted: 2016-10-06
Terminated: 2017-09-07
Recalling firm: Randox Laboratories, Limited
Product: IgE Calibrator Series
Product code: DGC Ige, Antigen, Antiserum, Control
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: The firm plans on contacting each consignee about the recall.
Quantity in commerce: 4
Distribution: All consignees are in the US.
Product codes and lots: Catalogue number IE2492 Batch number 354213, 386994

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0050-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0050-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-12	2016-10-06

Product code DGC

K010855Class IIRandox IgeRandox Laboratories, Ltd. / cleared 2001-05-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)