FDA Medical Device Recalls (openFDA)
Randox Laboratories Ltd.: Liquid Cardiac Control, CQ5052
- Recall number
- Z-0381-2019
- Recalling firm
- Randox Laboratories Ltd.
- Product
- Liquid Cardiac Control, CQ5052
- Status
- Terminated
- Initiated
- 2018-10-02
- Posted
- not on file
- Terminated
- 2019-05-30
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- On October 2, 2018, the firm notified distributors of the recall via Expanded Urgent Medical Device Correction email. Customers were informed that the recall was related to previous recall REC334 on June 8, 2018. The firm has confirmed that Liquid Cardiac Controls CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials. Customers were advised to take the following actions: - Discontinue use of these products for the Quality Control (QC) monitoring of Troponin T assays. - Discuss the contents of this notice with your Medical Director. - Update kits with revised IFUs excluding Troponin T values and the attached important notice to prevent further use of the device in the QC of Troponin T assays. - Complete and return the vigilance response section of this form to technical.services@randox.com within five working days. - Contact your local Randox sales representative for alternative product details. You may contact the firm at technical.services@randox.com.
- Quantity
- 1738
- Distribution
- Distributed to IN, NY, PR, and WV.
- Lot, serial or model codes
- All lots
- 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