Z-2059-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 13, 2018
- Initiation Date
- May 4, 2018
- Termination Date
- June 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 41 analyzers
Product Description
RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
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 Pattern
US Distribution including Puerto Rico and the state of : West Virginia.
Code Information
GTIN 05055273206104. All serial numbers.