Lower riskMedical device recall · FDA · Published October 2, 2018
Randox Liquid Cardiac Control CQ5053: Unacceptable Assay Variation Recall
Randox recalls Liquid Cardiac Control CQ5053 due to unacceptable variation in Troponin T assay results. Affected units may cause inaccurate test results.
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 the Troponin T assay due to unacceptable variation between vials.
“Randox Liquid Cardiac Control CQ5053: Unacceptable Assay Variation Recall.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69695-randox-liquid-cardiac-control-cq5053-unacceptable-assay-variation-recall. Based on FDA recall #Z-0382-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0382-2019%22&limit=1).
The FDA announced on Oct. 2, 2018, that Randox Laboratories Ltd. is recalling Liquid Cardiac Control CQ5053 because the controls are no longer suitable for Troponin T assay control due to unacceptable variation between vials. The firm initiated this voluntary Class II recall.
How to tell if you have it
Brand: Randox
Product: Liquid Cardiac Control, CQ5051, CQ5052 and CQ5053
Lot codes: All lots
Units affected: 2108
The hazard
The Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials. The firm has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018.
Context
GovInfoNow's records show Randox Laboratories Ltd. has 49 other recalls on record since 2024-06-07. Other recent recalls of similar products include Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (2026-07-13), Roche Elecsys Anti-TSHR Assay Recall (2025-11-21) and Beckman Coulter Emit 2000 Quinidine Assay Recall (2026-07-13).
How to tell if you have this one
Check for Liquid Cardiac Control CQ5053 products with any lot number. The recall covers all lots of this product.
Brand
Randox
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Distributed to IN, NY, PR, and WV.
Recall number
Product, codes & lots
Quantity
Z-0380-2019
Liquid Cardiac Control, CQ5051; All lots
1763
Z-0381-2019
Liquid Cardiac Control, CQ5052; All lots
1738
Z-0382-2019
Liquid Cardiac Control, CQ5053; All lots
2108
Based on the official FDA remedy
What to do — step by step
Check Product Lot
Identify the lot number on your Liquid Cardiac Control CQ5053 product.
Where it went and when
Where it was distributed
Distributed in 3 states and Puerto Rico.
Listed by the agency
Not listed
FDA distribution: “Distributed to IN, NY, PR, and WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Indiana, New York, Puerto Rico, West Virginia.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0382-2019 (October 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0382-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.