Recall Z-1349-2020 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
| Date | Feb 24, 2020 (initiated Dec 19, 2019) |
| Status | Terminated |
| 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-u |
| Quantity | U.S.: RX4040-2 units RX 4041-3 units |
| Distribution | US Nationwide distribution including state of PR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131554 | RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT Randox Laboratories, Ltd., Jan 9, 2014 |