Radiometer America recalls

Radiometer America has 24 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 28 Aug 2019.

Total recalls24since 2012

Last 12 months0reported

Class I00% of total

Ongoing0latest 28 Aug 2019

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 23 96%Class III 1 4%

Why radiometer america is recalled

Product types

By year

2019313%
201814%
2017417%
2016313%
2015313%
2014521%
2013313%
201228%

All radiometer america recalls, newest first

24 total

Reported	Class	Recall	Company	Reason	Where
28 Aug 2019Device	CLASS II	ABL90 FLEX Analyzer recalled by Radiometer America	Radiometer America	Device Malfunction	36 states
13 Feb 2019Device	CLASS II	ABL800 FLEX with Crea recalled by Radiometer America	Radiometer America	Other	31 states
2 Jan 2019Device	CLASS II	ABL800 analyzer recalled by Radiometer America	Radiometer America	Device Malfunction	Nationwide
10 Oct 2018Device	CLASS II	ABL90 FLEX analyzers recalled by Radiometer America	Radiometer America	Device Malfunction	Nationwide
20 Dec 2017Device	CLASS II	ABL800 analyzer with Flexq module recalled by Radiometer America	Radiometer America	Other	Nationwide
11 Oct 2017Device	CLASS II	AutoCheck5+, Level 2, specifically designed recalled	Radiometer America	Device Malfunction	Nationwide
22 Mar 2017Device	CLASS II	The ABL800 recalled by Radiometer America	Radiometer America	Other	Nationwide
22 Mar 2017Device	CLASS II	ABL90 Flex recalled by Radiometer America	Radiometer America	Other	Nationwide
28 Dec 2016Device	CLASS II	Aqure System recalled by Radiometer America	Radiometer America	Potency & Assay	Nationwide
11 May 2016Device	CLASS II	TCM CombiM Modules recalled by Radiometer America	Radiometer America	Device Malfunction	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.