Recall Z-1463-2017— Radiometer America Inc

Name: FDA recall Z-1463-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-26

Class II · Terminated

Class II FDA medical device recall by Radiometer America Inc, initiated 2017-01-26, terminated 2018-02-20. It names one FDA 510(k) clearance: K041874. Product: The ABL800 Model#:All. Reason: Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous..

Recalling firm: Radiometer America Inc
Classification: Class II
Status: Terminated
Initiated: 2017-01-26
Terminated: 2018-02-20
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

The ABL800 Model#:All

Reason for recall

Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.

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