Reported Jun 13, 2018 · Terminated
RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
Randox Laboratories
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 · 515 Industrial Blvd · Kearneysville, WV · 25430-2778
Is this the product you have?
- RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
- Lot codes and dates
- GTIN 05055273206104. All serial numbers.
- Amount recalled
- 41 analyzers
Where it was sold
Why it was recalled
Abnormal premature termination of the software could affect the use of the analyser when running patient samples. The impact being a delay in reporting test results.
This product could cause temporary or reversible health problems — stop using it.
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