Z-1349-2020Class II

RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) -

Name: Z-1349-2020 RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) -
Creator: Randox Laboratories, Limited
Published: 2019-12-19
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2019-12-19 / Terminated / root cause: software

FDA source

Randox Laboratories, Limited began a recall of RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully automated, random access, clinical... on 2019-12-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1349-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-19
Posted: 2020-02-24
Terminated: 2021-04-23
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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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."
Root cause tag: software
FDA 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 in commerce: U.S.: RX4040-2 units RX 4041-3 units
Distribution: US Nationwide distribution including state of PR.
Product codes and lots: Software version UI2550642107 for the RX Daytona Plus instrument.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1349-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1349-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-24

Product code JJE

K131554Class IRx Daytona Plus Chemistry Analyzer; Rx Daytona Plus Aspartate Aminotransferase (Ast) ReagentRandox Laboratories, Ltd. / cleared 2014-01-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)