Recall Z-0682-2019— Radiometer America Inc

Name: FDA recall Z-0682-2019
Creator: U.S. Food and Drug Administration
Published: 2018-07-03

Class II · Terminated

Class II FDA medical device recall by Radiometer America Inc, initiated 2018-07-03, terminated 2023-08-30. It names one FDA 510(k) clearance: K041874. Product: ABL800 analyzer, model numbers 393-800 and 393-801.. Reason: The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur..

Recalling firm: Radiometer America Inc
Classification: Class II
Status: Terminated
Initiated: 2018-07-03
Terminated: 2023-08-30
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K041874 — ABL800 FLEXRadiometer Medical Aps·cleared 2004-10-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.