Recall Z-2059-2018
Randox Laboratories · initiated May 4, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
Codes / lots: GTIN 05055273206104. All serial numbers.
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.
FDA-determined 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.
Details
- Recall number
- Z-2059-2018
- Initiated
- May 4, 2018
- Terminated
- June 16, 2020
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 41 analyzers
- Distribution
- US Distribution including Puerto Rico and the state of : West Virginia.
- Recalling firm
- Randox Laboratories, Kearneysville, WV