Recall Z-0412-2020— Randox Laboratories, Limited

Name: FDA recall Z-0412-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-04

Class II · Terminated

Class II FDA medical device recall by Randox Laboratories, Limited, initiated 2019-10-04, terminated 2020-07-06. It names one FDA 510(k) clearance: K110534. Product: Randox Liquid Cardiac Controls Catalogue Number CQ5051. Reason: 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..

Recalling firm: Randox Laboratories, Limited
Classification: Class II
Status: Terminated
Initiated: 2019-10-04
Terminated: 2020-07-06
Firm location: Crumlin, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K110534 — RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3Randox Laboratories Limited·cleared 2012-01-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Randox Liquid Cardiac Controls Catalogue Number CQ5051

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.