Z-0414-2020Class II

Randox Liquid Cardiac Controls Catalogue Numbers CQ5053

Name: Z-0414-2020 Randox Liquid Cardiac Controls Catalogue Numbers CQ5053
Creator: Randox Laboratories, Limited
Published: 2019-10-04
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2019-10-04 / Terminated

FDA source

Randox Laboratories, Limited began a recall of Randox Liquid Cardiac Controls Catalogue Numbers CQ5053 on 2019-10-04. FDA classified it as Class II and gives the reason as "Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5053 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0414-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-04
Posted: 2019-11-15
Terminated: 2020-07-06
Recalling firm: Randox Laboratories, Limited
Product: Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5053 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots.
FDA root cause: Under Investigation by firm
Action: On October 1, 2019 the firm distributed Urgent Medical Device Recall letters by e-mail instructing them to: - 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 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: 6,702
Distribution: US Distribution: WV, CA, DE, NJ, NY, GA, IN, PR OUS Distribution: CA, PL, CH, JP, NL, IT, CN, GB, IE, RU, MD, BY, SA, VN, AE, BH, DK, CO, ES, FR, TW, PH, TH, OM, HU, IN, KR, ZA, AU, CZ, PE, CL, IR, NZ, BE, DE, BA, SV, SK, HK, PT, PK, BR, TR, UA, SE, QA, LT, PE,
Product codes and lots: Catalogue Number: CQ5053 GTIN: 05055273207460 Batch/lot: 4245CK (Exp. 28Nov2019), 4248CK (Exp. 28Nov2019), 4313CK (Exp. 28Jun2020) and 4316CK (Exp. 28Jun2020)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0414-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0412-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-27	2019-11-15
Z-0413-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-27	2019-11-15
Z-0414-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-27	2019-11-15

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)