FDA recall Z-0682-2019

Radiometer America Inc · Class II · device

Product

ABL800 analyzer, model numbers 393-800 and 393-801.

Reason for recall

The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.

Distribution

Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Canada.

Key facts

Status
Terminated
Initiation date
2018-07-03
Report date
2019-01-02
Termination date
2023-08-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Brea, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0682-2019