FDA Medical Device Recalls (openFDA)
Randox Laboratories, Limited: RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully automated, random access, clinical chemistry analyzer complete with dedicated analyzer software. For use in clinical laboratories.
- Recall number
- Z-1349-2020
- Recalling firm
- Randox Laboratories, Limited
- Product
- RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully automated, random access, clinical chemistry analyzer complete with dedicated analyzer software. For use in clinical laboratories.
- Status
- Terminated
- Initiated
- 2019-12-19
- Posted
- 2020-02-24
- Terminated
- 2021-04-23
- Reason
- Software version UI2550642107 for the RX Daytona + instrument released to correct the following issues: 1) The order of samples displayed is not sequential according to SID (sample identification number) when searching the run/results screen; 2) Incorrect color flagging of IQC as "out of range."
- Root cause
- Under Investigation by firm
- Action
- Randox Medical Device Correction letter dated 12.17.2019. The recall from the manufacturer is extended to the distribution center within the USA and Puerto Rico. The distributor will then contact the customer directly. The initial contact and the follow up contact will be via email. If further contacts are required these will be via telephone. It is intended that the initial contact will be conducted 19th December 2019. The distributors and customers will be instructed to read and review the release notes and carry-out all actions specified within. Distributors are advised to contact all end-users and provide the FSN, response form and release notes. Customers were advised to take the following actions: complete and return the response form 12187-QA to technical.services@randox .com within five working days. ***Updated 3/2/2020*** The firm sent an updated customer letter on February 28, 2020, which included an updated "Risk to Health" statement, which now states that a delay in reporting results could lead to a delay in diagnosis and/or treatment. No erroneous patient results are generated due to this issue. Instructions to customers have not changed.
- Quantity
- U.S.: RX4040-2 units RX 4041-3 units
- Distribution
- US Nationwide distribution including state of PR.
- Lot, serial or model codes
- Software version UI2550642107 for the RX Daytona Plus instrument.
- 510(k) numbers
- ["K131554"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 1000361607
- Firm city
- Crumlin
- Firm state
- not on file
- Firm country
- United Kingdom
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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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