Z-2575-2018Class II

Liquid Cardiac Control - Level 3, cat. no. CQ5053

Name: Z-2575-2018 Liquid Cardiac Control - Level 3, cat. no. CQ5053
Creator: Randox Laboratories Ltd.
Published: 2018-06-08
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2018-06-08 / Terminated

FDA source

Randox Laboratories Ltd. began a recall of Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Cardiac... on 2018-06-08. FDA classified it as Class II and gives the reason as "The device is not suitable for the control of the Troponin T assay due to unacceptable variation between vials. The deviation in precision observed is up to 28%. IQC that is reported as out of range could lead to a...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2575-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-08
Posted: 2018-07-30
Terminated: 2018-11-05
Recalling firm: Randox Laboratories, Limited
Product: Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: The device is not suitable for the control of the Troponin T assay due to unacceptable variation between vials. The deviation in precision observed is up to 28%. IQC that is reported as out of range could lead to a delay in reporting Troponin T results. If the failure occurs the operator may observe the quality control result for Troponin T falling outside range and/or increased imprecision for Quality Control monitoring.
FDA root cause: Under Investigation by firm
Action: On June 8, 2018, the firm issued an Urgent Medical Device Recall letter to affected consignees. The letter stated that Randox has confirmed Liquid Cardiac Control CQ5053 Lot: 4245CK is not suitable for the control of the Troponin T assay due to unacceptable variation between vials. The deviation in precision observed is up to 28%. Customers were instructed to do the following: " 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. " Update kits with corrected IFU's excluding Troponin T values. " Complete and return the vigilance response section of this form to [email protected] within five working days.) In addition, distributors were instructed to send a copy of the letter to all affected customers and to those who need to be aware within their organization.
Quantity in commerce: 1 kit (US), 602 kits (OUS)
Distribution: Worldwide Distribution - US in the state of WV. Foreign distribution to Australia, Chile, China, Germany, Hungary, Ireland, Italy, Moldova, Netherlands, Peru, Poland, Saudi Arabia, Slovakia, Spain, Sultanate of Oman, UAE, UK, and Vietnam
Product codes and lots: Lot 4245CK.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2575-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2575-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-29

Product code JJY

K110534Class IRandox Liquid Cardiac Control Levels 1, 2 and 3Randox Laboratories Limited / cleared 2012-01-23

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)