CLASS II Device recall · Reported 27 Nov 2019 · FDA Enforcement Report
Randox Liquid Cardiac Controls recalled by Randox Laboratories
Randox Laboratories is recalling Randox Liquid Cardiac Controls, distributed in 10 states. The recall was initiated on 4 Oct 2019 and the FDA has classified it as Class II.
Check your package
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-0413-2020
- FDA event ID
- 84044
- Recalling firm
- Randox Laboratories, Crumlin, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Oct 2019
- FDA classified
- 15 Nov 2019
- Reported
- 27 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 4 Oct 2019 | Recall initiated by company | |
| 15 Nov 2019 | Classified by FDA | +42 days |
| 27 Nov 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
Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5052 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots.
Product as listed by the FDA
Randox Liquid Cardiac Controls Catalogue Number CQ5052.
Where it was distributed
US Distribution: WV, CA, DE, NJ, NY, GA, IN, PR OUS Distribution: CA, PL, CH, JP, NL, IT, CN, GB, IE, RU, MD, BY, SA, VN, AE, BH, DK, CO, ES, FR, TW, PH, TH, OM, HU, IN, KR, ZA, AU, CZ, PE, CL, IR, NZ, BE, DE, BA, SV, SK, HK, PT, PK, BR, TR, UA, SE, QA, LT, PE,
CaliforniaColoradoDelawareGeorgiaIndianaMarylandNew JerseyNew YorkPuerto RicoWest Virginia
Questions about this recall
Is Randox Liquid Cardiac Controls recalled?
Yes. Randox Laboratories recalled Randox Liquid Cardiac Controls on 4 Oct 2019. The recall is Class II and its status is Terminated. Recall number Z-0413-2020.
Why was it recalled?
Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5052 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots.
Which lots are affected?
Catalogue Number: CQ5052 GTIN: 05055273207453 Batch/lot: 4244CK (Exp. 28Nov2019), 4247CK (Exp. 28Nov2019), 4261CK (Exp. 28Nov2019), 4312CK Exp. 28Jun2020) and 4315CK (Exp. 28Jun2020)
Where was it sold?
US Distribution: WV, CA, DE, NJ, NY, GA, IN, PR OUS Distribution: CA, PL, CH, JP, NL, IT, CN, GB, IE, RU, MD, BY, SA, VN, AE, BH, DK, CO, ES, FR, TW, PH, TH, OM, HU, IN, KR, ZA, AU, CZ, PE, CL, IR, NZ, BE, DE, BA, SV, SK, HK, PT, PK, BR, TR, UA, SE, QA, LT, PE,
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 |
|---|---|---|---|---|---|
| Device | CLASS II | Randox Lipoprotein (a) - In vitro diagnostic recalled | Randox Laboratories | Potency & Assay | Nationwide |
| Device | CLASS II | Randox Lipoprotein (a) - In vitro diagnostic recalled | Randox Laboratories | Potency & Assay | Nationwide |
| Device | CLASS II | RX Series CYSC- Cystatin C Reagent -Intended recalled | Randox Laboratories | Potency & Assay | Nationwide |
| Device | CLASS II | Clinical Chemistry Calibration Serum recalled by Randox Laboratories | Randox Laboratories | Other | Nationwide |
| Device | 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 |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |