Z-0362-2023Class II

IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number...

Name: Z-0362-2023 IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number...
Creator: Randox Laboratories Ltd.
Published: 2022-11-01
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2022-11-01 / Terminated

FDA source

Randox Laboratories Ltd. began a recall of IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832 on 2022-11-01. FDA classified it as Class II and gives the reason as "Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immediately after Fructosamine Catalogue Number FR3133 or FR4030 on the RX instruments testing order. Can lead to...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0362-2023
Classification: Class II
Status: Terminated
Initiated: 2022-11-01
Posted: 2022-12-03
Terminated: 2024-06-18
Recalling firm: Randox Laboratories, Limited
Product: IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832
Product code: CZP Iga, Antigen, Antiserum, Control
Reason for recall: Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immediately after Fructosamine Catalogue Number FR3133 or FR4030 on the RX instruments testing order. Can lead to an elevation in Quality Control and Patient results of up to +13% for lgA and +51% for lgM respectively, which may lead to a delay in running patient samples or erroneous elevated test results
FDA root cause: Under Investigation by firm
Action: Randox Laboratories extended recall notification to the US Distribution center on 11/01/22 via email. The US distributor contacted customers on 11/1/22 via email . Letter states reason for recall, health risk and action to take: Review your instrument testing order in line with the Carryover Avoidance Technical Bulletin (RXTB-0136} " Update the RX user manual with the updated Carryover Avoidance Technical Bulletin (RXTB-0136} and ensure all operators are aware of the recommendations. Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to [email protected] within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation. If you have any questions or concerns, please contact Randox Technical Services
Quantity in commerce: 20 kits US in total
Distribution: US Nationwide Distribution: CA, NC, NJ and WV,
Product codes and lots: GTIN: 05055273203882 All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0362-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0362-2023	Class II	Terminated	Voluntary: Firm initiated	2022-12-14	2022-12-02
Z-0363-2023	Class II	Terminated	Voluntary: Firm initiated	2022-12-14	2022-12-02

Product code CZP

K955794Class IIIga Immunoturbidimetric & CalibratorRandox Laboratories, Ltd. / cleared 1996-04-05

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)