Recall Z-2084-2019 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Randox Laboratories, Limited
RX Imola, Model Nos. RX4900
| Date | Jun 24, 2019 |
| Status | Terminated |
| Reason | There was a report of a malfunction with the sensor which resulted in an increase of temperature leading to melting of internal wires and scorch damage to the internal structure of the instrument. |
| Root cause | Under Investigation by firm |
| Action | On June 24, 2019, the firm notified its customers of the recall through an Urgent Field Safety Notice. Customers were asked to take the following actions: If there is any sign of damage to the RCU lid or lid sensor " Switch of main analyser main power supply as soon as possible " Contact technical support immediately. " Discuss the contents of this notice with your Medical Director. " Display this notice in a prominent location near the instrument. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. |
| Quantity | 27 |
| Distribution | Domestic distribution to CA CT MA MD MO NC NJ NY OH PA UT WV and PR. Worldwide foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052914 | RX IMOLA Randox Laboratories, Ltd., Mar 31, 2006 |