Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom Randox Liquid Cardiac Controls Catalogue Number CQ5051 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Removal of claims for N-proBNP in the Liquid Cardiac Control model numbers CQ5051 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots.

Recommended Action

Per FDA guidance

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 technical.services@randox.com 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.

Distribution

As reported by FDA

CA, CO, DE, GA, IN, MD, NJ, NY, WV, PR