Company: Radiometer America Inc
Date of Enforcement Report: 12/22/2018
Class II
PRODUCT
ABL800 analyzer, model numbers 393-800 and 393-801.
Recall Number: Z-0682-2019
REASON
The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.
RECALLING FIRM/MANUFACTURER
Radiometer America Inc, Brea, CA on 7/3/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2,131 Analyzers
DISTRIBUTION
U.S. Nationwide (including Military/Government) and Canada