FDA Recall
Terminated
RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
Recall: Z-2059-2018
·
Initiated May 4, 2018
Recall
- Recall Number
- Z-2059-2018
- Event Number
- 79968
- Firm
- Randox Laboratories
- FEI Number
- 3003059701
- Product Code
- JJE
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- May 4, 2018
- Terminated
- June 16, 2020
- Address
- 515 Industrial Blvd, Kearneysville, WV, 25430-2778
Description
RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
Reason
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.
Action
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.
Distribution
US Distribution including Puerto Rico and the state of : West Virginia.
Quantity
41 analyzers