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.
Reported: March 4, 2020 Initiated: December 19, 2019 #Z-1349-2020
Product Description
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.
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."
Details
- Recalling Firm
- Randox Laboratories, Limited
- Units Affected
- U.S.: RX4040-2 units RX 4041-3 units
- Distribution
- US Nationwide distribution including state of PR.
- Location
- Crumlin, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Randox Laboratories, Limited. Units affected: U.S.: RX4040-2 units RX 4041-3 units.
Why was this product recalled? ▼
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."
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 4, 2020. Severity: Moderate. Recall number: Z-1349-2020.
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