Z-0904-2023Class II

Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on...

Name: Z-0904-2023 Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on...
Creator: Randox Laboratories Ltd.
Published: 2022-11-22
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2022-11-22 / Open, Classified

FDA source

Randox Laboratories Ltd. began a recall of Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog... on 2022-11-22. FDA classified it as Class II and gives the reason as "Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0904-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-22
Posted: 2023-01-05
Recalling firm: Randox Laboratories, Limited
Product: Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
FDA root cause: Under Investigation by firm
Action: Randox Laboratories Ltd issued via email to the US Distributor Randox Laboratories-US, Ltd., Kearneysville, West Virginia on 11/22/22. The US Distributor contacted the customers by letter on 11/28/22. The Urgent Medical Device Correction letter states reason for recall, health risk and action to take: Discard previous IFUs and download the updated IFUs from randox.com Review results generated with the affected batches in line with the clinical profile of the patient. 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 organization.
Quantity in commerce: 115 units
Distribution: US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.
Product codes and lots: GTIN: 05055273204902 Lot Number/Exp. Date: 585LPC 28thJun 23; 601LPC 28th Nov 23; 612LPC 28th Sep 24

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0904-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0903-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-11	2023-01-05
Z-0904-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-11	2023-01-05
Z-0905-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-11	2023-01-05

Product code JJY

K972608Class IRandox Assayed Specific Protein ControlRandox Laboratories, Ltd. / cleared 1997-08-04

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)