Radiometer America Inc: 15 recalls on record

Recalls filed with 1 agency: FDA (15).

First recall on record: August 15, 2012. Most recent: January 2, 2019.

Risk classification: Class II: 14 · Class III: 1

Most recent recalls

DateAgencyProduct
January 2, 2019FDAABL800 analyzer, model numbers 393-800 and 393-801.Z-0682-2019
October 11, 2017FDAAutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers …Z-3237-2017
March 22, 2017FDAABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gas…Z-1462-2017
May 11, 2016FDATCM CombiM Modules 903-111Z-1595-2016
December 31, 2014FDAHemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed fo…Z-0873-2015
September 17, 2014FDARADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing applicat…Z-2597-2014
March 5, 2014FDApCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automat…Z-1075-2014
January 29, 2014FDAABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 Br¿nsh¿j, Denmark A portable,…Z-0816-2014
January 22, 2014FDApO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2…Z-0713-2014
October 9, 2013FDALactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in…Z-2303-2013
August 14, 2013FDATCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21…Z-1930-2013
January 2, 2013FDAQualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is …Z-0608-2013
August 15, 2012FDAThe ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are inten…Z-2163-2012
August 15, 2012FDAThe ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the…Z-2162-2012
August 15, 2012FDAABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro te…Z-2164-2012

Questions about this company

How many recalls does Radiometer America Inc have?
Recalert has 15 U.S. recalls on record for Radiometer America Inc, published between August 15, 2012 and January 2, 2019.
What was the most recent Radiometer America Inc recall?
FDA recall Z-0682-2019, published January 2, 2019: ABL800 analyzer, model numbers 393-800 and 393-801.
Which agencies have handled Radiometer America Inc recalls?
Radiometer America Inc appears as the recalling firm in recalls from: FDA (15).

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