FDA Device

RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.

Hazard

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.

What You Should Do

Remedy

All customers will be contacted directly by email and will be followed up with once every 2 weeks over a period of 6 weeks. Customers are advised to update the software in all analyzers. For further questions, please call 1 (866)472-6369.

Products

RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
Brand
Randox Laboratories
UPC
GTIN 05055273206104. All serial numbers.

Units Affected

41 analyzers