Z-1785-2019Class II

Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053

Name: Z-1785-2019 Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053
Creator: Randox Laboratories Ltd.
Published: 2019-03-11
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2019-03-11 / Terminated

FDA source

Randox Laboratories Ltd. began a recall of Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053 on 2019-03-11. FDA classified it as Class II and gives the reason as "Customers may observe a decrease in recovered concentration with regards to NTproBNP in the Liquid Cardiac Control lots identified, on the Siemens Dimension EXL LOCI". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1785-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-11
Posted: 2019-06-14
Terminated: 2020-05-15
Recalling firm: Randox Laboratories, Limited
Product: Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: Customers may observe a decrease in recovered concentration with regards to NTproBNP in the Liquid Cardiac Control lots identified, on the Siemens Dimension EXL LOCI.
FDA root cause: Under Investigation by firm
Action: On March 11, 2019, the firm notified affected consignees of the product issue through an Urgent Medical Device Correction letter. Customers were informed that they may observe a decrease in recovered concentration for NTproBNP in the referenced Liquid Cardiac Control lots compared to the quoted target value on the value sheet for this analyzer only (Siemens Dimension EXL LOCI). Customers were asked to do the following: * Inspect your stock and quarantine affected stock. " Replace the value sheet in the kit with the revised value sheet provided. " Randox is not recommending a review of previous results as changes in quality control recovery would be reviewed at the time of occurrence. " Discuss the contents of this notice with your Medical Director. " Complete the response form even if you no longer have the affected product. Return the response form to [email protected] within five working days.
Quantity in commerce: 11420 kits
Distribution: Product distributed to CA, DE, WV, and Puerto Rico.
Product codes and lots: lots 4243CK, 4244CK, 4245CK.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1785-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1785-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-14

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)