CLASS II Device recall · Reported 26 Jun 2019 · FDA Enforcement Report

Liquid Cardiac Control recalled by Randox Laboratories

Randox Laboratories is recalling Liquid Cardiac Control, distributed in California, Delaware, Puerto Rico, West Virginia. The recall was initiated on 11 Mar 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codeslots 4243CK, 4244CK, 4245CK.

Quantity recalled11420 kits

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-1785-2019
FDA event ID: 82400
Recalling firm: Randox Laboratories, Crumlin (North), N/A
Classification: Class II
Status: Terminated
Recall initiated: 11 Mar 2019
FDA classified: 14 Jun 2019
Reported: 26 Jun 2019
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

11 Mar 2019	Recall initiated by company
14 Jun 2019	Classified by FDA	+95 days
26 Jun 2019	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

Customers may observe a decrease in recovered concentration with regards to NTproBNP in the Liquid Cardiac Control lots identified, on the Siemens Dimension EXL LOCI.

Product as listed by the FDA

Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053

Where it was distributed

Product distributed to CA, DE, WV, and Puerto Rico.

California Delaware Puerto Rico West Virginia

Questions about this recall

Is Liquid Cardiac Control recalled?

Yes. Randox Laboratories recalled Liquid Cardiac Control on 11 Mar 2019. The recall is Class II and its status is Terminated. Recall number Z-1785-2019.

Why was it recalled?

Customers may observe a decrease in recovered concentration with regards to NTproBNP in the Liquid Cardiac Control lots identified, on the Siemens Dimension EXL LOCI.

Which lots are affected?

lots 4243CK, 4244CK, 4245CK.

Where was it sold?

Product distributed to CA, DE, WV, and Puerto Rico.

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.

More recalls from Randox Laboratories

All 98

Reported	Class	Recall	Company	Reason	Where
29 Jan 2025Device	CLASS II	Randox Lipoprotein (a) - In vitro diagnostic recalled	Randox Laboratories	Potency & Assay	Nationwide
29 Jan 2025Device	CLASS II	Randox Lipoprotein (a) - In vitro diagnostic recalled	Randox Laboratories	Potency & Assay	Nationwide
31 Jul 2024Device	CLASS II	RX Series CYSC- Cystatin C Reagent -Intended recalled	Randox Laboratories	Potency & Assay	Nationwide
15 May 2024Device	CLASS II	Clinical Chemistry Calibration Serum recalled by Randox Laboratories	Randox Laboratories	Other	Nationwide
15 May 2024Device	CLASS III	Evidence MultiSTAT recalled by Randox Laboratories	Randox Laboratories	Packaging Defects	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide