CLASS II Device recall · Reported 14 Nov 2018 · FDA Enforcement Report

Liquid Cardiac Control, CQ5053 recalled by Randox Laboratories

Randox Laboratories is recalling Liquid Cardiac Control, CQ5053, distributed in Indiana, New York, Puerto Rico, West Virginia. The recall was initiated on 2 Oct 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots

Quantity recalled2108

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0382-2019
FDA event ID: 81159
Recalling firm: Randox Laboratories, Crumlin (North)
Classification: Class II
Status: Terminated
Recall initiated: 2 Oct 2018
FDA classified: 2 Nov 2018
Reported: 14 Nov 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Potency & Assay
Device type: Other Medical Devices

Timeline

2 Oct 2018	Recall initiated by company
2 Nov 2018	Classified by FDA	+31 days
14 Nov 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Liquid Cardiac Control, CQ5053

Where it was distributed

Distributed to IN, NY, PR, and WV.

Indiana New York Puerto Rico West Virginia

Questions about this recall

Is Liquid Cardiac Control, CQ5053 recalled?

Yes. Randox Laboratories recalled Liquid Cardiac Control, CQ5053 on 2 Oct 2018. The recall is Class II and its status is Terminated. Recall number Z-0382-2019.

Why was it recalled?

Which lots are affected?

All lots

Where was it sold?

Distributed to IN, NY, PR, and WV.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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