Z-1461-2020Class II

Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical...

Name: Z-1461-2020 Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical...
Creator: Response Biomedical Corp.
Published: 2019-03-15
License: https://open.fda.gov/license/

Response Biomedical Corp. / initiated 2019-03-15 / Terminated / root cause: design

FDA source

Response Biomedical Corp. began a recall of Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318) IFU: "RAMP Cardiac... on 2019-03-15. FDA classified it as Class II and gives the reason as "The form received three complaints related to the user obtaining a result that fell below the target range for CK-MB provided in the RAMP Cardiac Controls Instructions for Use. Via in-house monitoring, determined that...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1461-2020
Classification: Class II
Status: Terminated
Initiated: 2019-03-15
Posted: 2020-03-10
Terminated: 2022-06-09
Recalling firm: Response Biomedical Corp.
Product: Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318) IFU: "RAMP Cardiac Controls *** CAT. No.: C2003-2 *** Size: 3 x 3 ML". Product Usage: use in the quality control of cardiac marker assays run on the RAMP platform.
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: The form received three complaints related to the user obtaining a result that fell below the target range for CK-MB provided in the RAMP Cardiac Controls Instructions for Use. Via in-house monitoring, determined that liquid Cardiac Control has seen a decrease in CK-MB Levels of up to 57% signal loss within 11 months. Shelf-life of product is 24 months.
Root cause tag: design
FDA root cause: Device Design
Action: On 03/15/2019, the firm sent an "Field CORRECTION" Letter via email informing them that the specific lot (4244CK) has seen a decrease in CK-MB levels of up to 57% signal loss within 11 months of the Randox-stated shelf life of 24 months. Customers are instructed to: -Inspect their stock levels and report level of unused inventory; -Notify the Recalling Firm's Technical Support using Field Correction Response Form indicating the replacement quantity; -Confirm lot-specific ranges per website (www.responsebio.com/cardiaccountrols) -Substitute affected Lot # 070318 with replacement stock as appropriate. For any further questions or information contact Technical Support at [email protected].
Quantity in commerce: 543 units
Distribution: Worldwide distribution: US Nationwide distributions in the states of IN, GA, OK, KS, AZ, SC, NE, NC, MI, FL, CA, MN, and AR. Countries of Canada, Italy, Malaysia, Kuwait, Saudi Arabia, UAE, Ukraine, Russia, Dominican Republic, France, Mexico, Colombia, Singapore, China, Serbia, Romania, and Philippine.
Product codes and lots: Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318). UDI Code: (01) 1 0627966 00508 4 (10) 070318 (17)300919

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1461-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1461-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-18	2020-03-10

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)