FDA recall Z-2059-2018

Product

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

US Distribution including Puerto Rico and the state of : West Virginia.

Key facts

Status

Terminated

Initiation date

2018-05-04

Report date

2018-06-13

Termination date

2020-06-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kearneysville, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2059-2018