Recall Z-1857-2021— Radiometer Medical ApS

Name: FDA recall Z-1857-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-14

Class II · Ongoing

Class II FDA medical device recall by Radiometer Medical ApS, initiated 2021-04-14. It names one FDA 510(k) clearance: K160153. Product: Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.. Reason: Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed..

Recalling firm: Radiometer Medical ApS
Classification: Class II
Status: Ongoing
Initiated: 2021-04-14
Firm location: Bronshoj, Denmark

510(k) clearances named in this recall

1 on FDA's record

K160153 — ABL90 FLEX PLUSRadiometer Medical Aps·cleared 2016-11-04

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

Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.

Reason for recall

Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.

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