Z-0382-2019Class II

Liquid Cardiac Control, CQ5053

Name: Z-0382-2019 Liquid Cardiac Control, CQ5053
Creator: Randox Laboratories Ltd.
Published: 2018-10-02
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2018-10-02 / Terminated

FDA source

Randox Laboratories Ltd. began a recall of Liquid Cardiac Control, CQ5053 on 2018-10-02. FDA classified it as Class II and gives the reason as "Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0382-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-02
Posted: 2018-11-03
Terminated: 2019-05-30
Recalling firm: Randox Laboratories, Limited
Product: Liquid Cardiac Control, CQ5053
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials.
FDA root cause: Under Investigation by firm
Action: On October 2, 2018, the firm notified distributors of the recall via Expanded Urgent Medical Device Correction email. Customers were informed that the recall was related to previous recall REC334 on June 8, 2018. The firm has confirmed that Liquid Cardiac Controls CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials. Customers were advised to take the following actions: - Discontinue use of these products for the Quality Control (QC) monitoring of Troponin T assays. - Discuss the contents of this notice with your Medical Director. - Update kits with revised IFUs excluding Troponin T values and the attached important notice to prevent further use of the device in the QC of Troponin T assays. - Complete and return the vigilance response section of this form to [email protected] within five working days. - Contact your local Randox sales representative for alternative product details. You may contact the firm at [email protected].
Quantity in commerce: 2108
Distribution: Distributed to IN, NY, PR, and WV.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0382-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0380-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-02
Z-0381-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-02
Z-0382-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-02

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