510(k) · Cleared
Recalled · Class II · 2019Randox Liquid Cardiac Control Levels 1, 2 and 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories Limited · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Jan 23, 2012 after a 332-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 11 times.
- Decided
- Jan 23, 2012
- Review
- 332 days
- Class
- Class I
- Product code
- JJY
- Recalls
- 11
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JJY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 4, 2019 | Class II | Z-0412-2020 | Under Investigation by firm | Removal of claims for N-proBNP in the Liquid Cardiac Control model numbers CQ5051 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots. |
| Oct 4, 2019 | Class II | Z-0414-2020 | Under Investigation by firm | Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5053 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots. |
| Oct 4, 2019 | Class II | Z-0413-2020 | Under Investigation by firm | 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. |
| Mar 15, 2019 | Class II | Z-1461-2020 | Device Design | The form received three complaints related to the user obtaining a result that fell below the target range for CK-MB provided in the RAMP Cardiac Controls Instructions for Use. Via in-house monitoring, determined that liquid Cardiac… |
| Mar 11, 2019 | Class II | Z-1785-2019 | Under Investigation by firm | 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. |
| Oct 2, 2018 | Class II | Z-0380-2019 | Under Investigation by firm | 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… |
| Oct 2, 2018 | Class II | Z-0381-2019 | Under Investigation by firm | 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… |
| Oct 2, 2018 | Class II | Z-0382-2019 | Under Investigation by firm | 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… |
| Jun 8, 2018 | Class II | Z-2575-2018 | Under Investigation by firm | The device is not suitable for the control of the Troponin T assay due to unacceptable variation between vials. The deviation in precision observed is up to 28%. IQC that is reported as out of range could lead to a delay in reporting… |
| Aug 8, 2017 | Class II | Z-0937-2018 | Unknown/Undetermined by firm | Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot 4069CK does not meet the shelf-life claim in the product labelling. As the control may now fall outside the provided control ranges the… |
| Sep 16, 2016 | Class II | Z-0762-2017 | Nonconforming Material/Component | 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… |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Randox Liquid Cardiac Controls Level 1, Level 2 and Level 3 are liquid controls containing BNP, OK MB Mass. Digoxin, D-Dimer, Homacysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I and Troponin T. They have been developed far use in the quality control of BNP, OK MB Mass, Digoxin, D-Dimer. Homocysteine, hsCRP, Myoglabin, 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
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K110534 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110534: Randox Liquid Cardiac Control Levels 1, 2 and 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110534
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026