Recall Z-1321-2022— Radiometer Medical ApS

Name: FDA recall Z-1321-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-18

Class II · Ongoing

Class II FDA medical device recall by Radiometer Medical ApS, initiated 2022-05-18. It names one FDA 510(k) clearance: K041874. Product: ABL800 Flex Analyzer Model Numbers 393-800 and 393-801. Reason: There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+..

Recalling firm: Radiometer Medical ApS
Classification: Class II
Status: Ongoing
Initiated: 2022-05-18
Firm location: Bronshoj, N/A, Denmark

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 Flex Analyzer Model Numbers 393-800 and 393-801

Reason for recall

There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+.

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