FDA Medical Device Recalls (openFDA)
Randox Laboratories Ltd.: Calibration Serum Level 3 CAL2351
- Recall number
- Z-0752-2024
- Recalling firm
- Randox Laboratories Ltd.
- Product
- Calibration Serum Level 3 CAL2351
- Status
- Open, Classified
- Initiated
- 2023-11-20
- Posted
- 2024-01-18
- Terminated
- not on file
- Reason
- CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.
- Root cause
- Under Investigation by firm
- Action
- Randox issued Urgent Medical Device Correction Letter via email to the US and PR Distributors on 11/20/23. Distributors contacted the customer directly. The Letter states reason for recall, health risk and action to take: Action to be taken: " Discuss the contents of this notice with your Medical Director if you have used the RX Series targets for CK Total in the aforementioned lots. " Complete and return the response form, 12187-QA to technical.services@randox.com within five working days. " Please discard all copies of the IFUs and download the latest versions from www.randox.com. If you have any questions or concerns please contact Randox Technical Services.
- Quantity
- 269 kits
- Distribution
- US Nationwide and Puerto Rico.
- Lot, serial or model codes
- GTIN: 05055273200966 Lot Numbers: 1214UE, 1249UE, 1260UE, 1262UE, 1268UE, 1297UE, 1298UE, 1315UE
- 510(k) numbers
- ["K053153"]
- PMA numbers
- not on file
- Product code
- JIX
- 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