Reported Mar 4, 2020 · Terminated
RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully…
Randox Laboratories, Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Randox Laboratories, Limited · Ardmore; 55 The Diamond Road · Crumlin, N/A · N/A
Is this the product you have?
- RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and
- RX4041 (without ISE) - Product UsageA fully automated, random access, clinical chemistry analyzer complete with dedicated analyzer software. For use in clinical laboratories
- Lot codes and dates
- Software version UI2550642107 for the RX Daytona Plus instrument.
- Amount recalled
- U.S.: RX4040-2 units RX 4041-3 units
Where it was sold
- Nationwide
- PR
Why it was 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."
This product could cause temporary or reversible health problems — stop using it.
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