RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
- Company
- Randox Laboratories
- Recall Initiated
- May 4, 2018
- Terminated
- June 16, 2020
- Recall Number
- Z-2059-2018
- Quantity
- 41 analyzers
- Firm Location
- Kearneysville, WV
Reason for Recall
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.
Distribution
US Distribution including Puerto Rico and the state of : West Virginia.
Lot / Code Info
GTIN 05055273206104. All serial numbers.
Root Cause
Under Investigation by firm
Action Taken
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.