Z-0937-2018Class II

Liquid Cardiac Control CQ5053

Name: Z-0937-2018 Liquid Cardiac Control CQ5053
Creator: Randox Laboratories, Limited
Published: 2017-08-08
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2017-08-08 / Terminated / root cause: labeling and UDI

FDA source

Randox Laboratories, Limited began a recall of Liquid Cardiac Control CQ5053 on 2017-08-08. FDA classified it as Class II and gives the reason as "Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot 4069CK does not meet the shelf-life claim in the product labelling. As the control may now fall outside the provided...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0937-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-08
Posted: 2018-03-09
Terminated: 2018-09-05
Recalling firm: Randox Laboratories, Limited
Product: Liquid Cardiac Control CQ5053
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot 4069CK does not meet the shelf-life claim in the product labelling. As the control may now fall outside the provided control ranges the product is to be recalled from the field.
Root cause tag: labeling and UDI
FDA root cause: Unknown/Undetermined by firm
Action: A recall notice was issued to customers on August 1, 2017 instructing them to discontinue use of product, discard remaining product for reimbursement and provide documentation of destruction.
Quantity in commerce: 450 kits
Distribution: Nationally
Product codes and lots: Lot 4069CK

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0937-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0937-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09

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)