CLASS II Device recall · Reported 21 Dec 2016 · FDA Enforcement Report
The Randox Liquid Cardiac Controls Level 1, Level recalled
Randox Laboratories is recalling The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls. The recall was initiated on 16 Sep 2016 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-0762-2017
- FDA event ID
- 75262
- Recalling firm
- Randox Laboratories, Antrim
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Sep 2016
- FDA classified
- 14 Dec 2016
- Reported
- 21 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 16 Sep 2016 | Recall initiated by company | |
| 14 Dec 2016 | Classified by FDA | +89 days |
| 21 Dec 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An internal real-time stability monitoring program revealed decreased recovery of myoglobin (-20% bias) for Randox Immunoturbidimetric and Siemens Centaur Classic methods and CKMB (-21% bias) for Roche e411, BioMerieux Vidas, and Siemens Centaur Classic methods.
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
The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T. They have been developed for use in the quality control of BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T assays on various clinical chemistry and immunoassay systems. This in vitro diagnostic device is intended for prescription use only.
Where it was distributed
Worldwide Distribution - US Distribution.
Questions about this recall
Is The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls recalled?
Yes. Randox Laboratories recalled The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls on 16 Sep 2016. The recall is Class II and its status is Terminated. Recall number Z-0762-2017.
Why was it recalled?
An internal real-time stability monitoring program revealed decreased recovery of myoglobin (-20% bias) for Randox Immunoturbidimetric and Siemens Centaur Classic methods and CKMB (-21% bias) for Roche e411, BioMerieux Vidas, and Siemens Centaur Classic methods.
Which lots are affected?
CQ5053 CQ5052
Where was it sold?
Worldwide Distribution - US Distribution.
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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