FDA Medical Device Recalls (openFDA)
Randox Laboratories Ltd.: Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053
- Recall number
- Z-1785-2019
- Recalling firm
- Randox Laboratories Ltd.
- Product
- Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053
- Status
- Terminated
- Initiated
- 2019-03-11
- Posted
- not on file
- Terminated
- 2020-05-15
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- On March 11, 2019, the firm notified affected consignees of the product issue through an Urgent Medical Device Correction letter. Customers were informed that they may observe a decrease in recovered concentration for NTproBNP in the referenced Liquid Cardiac Control lots compared to the quoted target value on the value sheet for this analyzer only (Siemens Dimension EXL LOCI). Customers were asked to do the following: * Inspect your stock and quarantine affected stock. " Replace the value sheet in the kit with the revised value sheet provided. " Randox is not recommending a review of previous results as changes in quality control recovery would be reviewed at the time of occurrence. " Discuss the contents of this notice with your Medical Director. " Complete the response form even if you no longer have the affected product. Return the response form to technical.services@randox.com within five working days.
- Quantity
- 11420 kits
- Distribution
- Product distributed to CA, DE, WV, and Puerto Rico.
- Lot, serial or model codes
- lots 4243CK, 4244CK, 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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