Recall Z-0382-2019— Randox Laboratories Ltd.

Name: FDA recall Z-0382-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-02

Class II · Terminated

Class II FDA medical device recall by Randox Laboratories Ltd., initiated 2018-10-02, terminated 2019-05-30. It names one FDA 510(k) clearance: K110534. Product: Liquid Cardiac Control, CQ5053. Reason: Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials..

Recalling firm: Randox Laboratories Ltd.
Classification: Class II
Status: Terminated
Initiated: 2018-10-02
Terminated: 2019-05-30
Firm location: Crumlin (North), Ireland

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

Liquid Cardiac Control, CQ5053

Reason for recall

Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials.

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