Z-0624-2024Class III

SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM...

Name: Z-0624-2024 SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM...
Creator: Randox Laboratories Ltd.
Published: 2023-11-06
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2023-11-06 / Open, Classified / root cause: manufacturing process

FDA source

Randox Laboratories Ltd. began a recall of SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to... on 2023-11-06. FDA classified it as Class III and gives the reason as "A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the DiaSorin Liaison XL". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0624-2024
Classification: Class III
Status: Open, Classified
Initiated: 2023-11-06
Posted: 2024-01-02
Recalling firm: Randox Laboratories, Limited
Product: SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxoplasma gondii, IgM antibodies to Herpes Simplex Virus Type 1 and 2. Catalog Number: SR10349
Product code: OHQ Multi-Analyte Controls Unassayed
Reason for recall: A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the DiaSorin Liaison XL.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Randox issued Urgent Medical Device Correction Letter on 11/6/23 to the US Distributor Randox Laboratories-US, Ltd. , Kearneysville, West Virginia, for issuance to the user level. Letter states reason for recall, health risk and action to take: As the control material is still testing positive for HSV Type 1/2 lgM, there is no risk to health. If the control did test negative for this analyte, the affected run should be discarded, and the samples re-analysed. Action to be taken: " 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. " Please discard all copies of the IFU and download the latest version from www.randox.com.alth risk and action to take: (
Quantity in commerce: 1 unit
Distribution: NY, WV
Product codes and lots: GTIN: 05055273216424 Bath/Lot Number: 157SR

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0624-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0624-2024	Class III	Ongoing	Voluntary: Firm initiated	2024-01-10	2024-01-02

Product code OHQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)