Device recall: The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass…
Class II FDA enforcement event 75262. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Randox Laboratories started this device recall on 16 Sep 2016. The firm address in the FDA record is in Antrim. FDA put the recall in Class II. FDA event 75262 has 1 product record. The first FDA enforcement report date is 21 Dec 2016. The record gives the status Terminated, with the termination date 11 Apr 2018.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution - US Distribution.
Recalling firm
Randox Laboratories, Antrim, United Kingdom.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0762-2017 | 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,… | 2817 | Class II | Terminated | 21 Dec 2016 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2016
- 1,232
- Share of these events in Class II
- 91%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 5
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 1 Feb 2023 | CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Cata | Device | Class II | 1 |
| 4 May 2018 | RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests. | Device | Class II | 1 |
| 11 Aug 2017 | Immunoassay Premium Controls (3x4x5mL and 12x5mL packages) | Device | Class III | 2 |
| 27 Apr 2017 | Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clini | Device | Class III | 1 |
Official channels
- FDA enforcement report Z-0762-2017The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 75262. https://recallregister.com/fda/ii/75262/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution - US Distribution.
- What quantity of product is in FDA event 75262?
- The FDA record gives this quantity:
2817
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2016 have the same class?
- 91% of the 1,232 device events that started in 2016 are in Class II.