RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully aut
FDA device recall Z-1349-2020 · posted 2020-02-24 · Terminated
Recall details
- Recalling firm
- Randox Laboratories, Limited
- Reason for recall
- 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."
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- U.S.: RX4040-2 units RX 4041-3 units
- Distribution
- US Nationwide distribution including state of PR.
- Date initiated
- 2019-12-19
- Date posted
- 2020-02-24
- Date terminated
- 2021-04-23
- Location
- Crumlin, United Kingdom
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT (K131554) | Randox Laboratories, Ltd. | 2014-01-09 |