FDA Medical Device Recalls (openFDA)
Randox Laboratories Ltd.: Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
- Recall number
- Z-2575-2018
- Recalling firm
- Randox Laboratories Ltd.
- Product
- Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
- Status
- Terminated
- Initiated
- 2018-06-08
- Posted
- not on file
- Terminated
- 2018-11-05
- Reason
- 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 Troponin T results. If the failure occurs the operator may observe the quality control result for Troponin T falling outside range and/or increased imprecision for Quality Control monitoring.
- Root cause
- Under Investigation by firm
- Action
- On June 8, 2018, the firm issued an Urgent Medical Device Recall letter to affected consignees. The letter stated that Randox has confirmed Liquid Cardiac Control CQ5053 Lot: 4245CK 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%. Customers were instructed to do the following: " Review results generated with the affected batches in line with the clinical profile of the patient. " Discuss the contents of this notice with your Medical Director. " Update kits with corrected IFU's excluding Troponin T values. " Complete and return the vigilance response section of this form to technical.services@randox.com within five working days.) In addition, distributors were instructed to send a copy of the letter to all affected customers and to those who need to be aware within their organization.
- Quantity
- 1 kit (US), 602 kits (OUS)
- Distribution
- Worldwide Distribution - US in the state of WV. Foreign distribution to Australia, Chile, China, Germany, Hungary, Ireland, Italy, Moldova, Netherlands, Peru, Poland, Saudi Arabia, Slovakia, Spain, Sultanate of Oman, UAE, UK, and Vietnam
- Lot, serial or model codes
- Lot 4245CK.
- 510(k) numbers
- ["K110534"]
- PMA numbers
- not on file
- Product code
- JJY
- Firm FEI
- 1000361607
- Firm city
- Crumlin
- Firm state
- North
- Firm country
- Ireland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28