Recall Z-2059-2018 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Randox Laboratories
RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
| Date | May 4, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| 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. |
| Quantity | 41 analyzers |
| Distribution | US Distribution including Puerto Rico and the state of : West Virginia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052914 | RX IMOLA Randox Laboratories, Ltd., Mar 31, 2006 |