Radiometer America Inc
Westlake, OH
This page shows every FDA and USDA recall linked to Radiometer America Inc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
52
Total Recalls
2005
First Recall
2015
Most Recent
Crea A and B membranes, packaged 4 per box
Used in conjunction with the ABL800 FLEX analyzers which are intend...
Mar 18, 2015
· Device
Terminated
ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases, elec...
Feb 9, 2015
· Device
Terminated
HemoCue Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue...
Dec 24, 2014
· Device
Terminated
RADIANCE v. 2.4X, 2.5X and 2.6X
Product Usage: RADIANCE is a data processing application for clinical use in...
Sep 6, 2014
· Device
Terminated
pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH.
An automatic or semi-automatic in...
Feb 24, 2014
· Device
Terminated
ABL90 FLEX Analyzer Radiometer Medical ApS, kandevej 21
Brnshj, Denmark
A portable, automated analyzer that m...
Jan 23, 2014
· Device
Terminated
pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145
pO2 membrane units, order...
Jan 10, 2014
· Device
Terminated
Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of sam...
Sep 30, 2013
· Device
Terminated
TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Brnshj, Denmark, ww...
Aug 8, 2013
· Device
Terminated
Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042.
The solution is used for quality check...
Dec 21, 2012
· Device
Terminated
ABL90 FLEX software version 2.7 MR3.
The ABL90 FLEX analyzer is intended for in vitro testing of samples of he...
Aug 8, 2012
· Device
Terminated
The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the in Vitro testing of:...
Aug 8, 2012
· Device
Terminated
The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro...
Aug 8, 2012
· Device
Terminated
S1827 Crea Calibration solution 1, 944-135, Lot DV-02 Radiometer Medical, Bronshoj Denmark
Product Usage:
The...
Feb 13, 2012
· Device
Terminated
TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003.
Product Usage: The device is intended for...
Dec 1, 2011
· Device
Terminated
Ca++ Membrane Units, Model #942-046, and Model #942-060 used on ABL505/555, EML105, ABL600, ABL700 Series, and...
Jun 16, 2011
· Device
Terminated
ABL90 FLEX Portable Blood Gas Analyzer System, Part Number: 393-090, 510 (k) #K092686. All units equipped wi...
Apr 28, 2011
· Device
Terminated
ABL90 FLEX Blood Analyzer Part Number: 393-090.
Intended for use by trained technologists, nurses, physician...
Feb 2, 2011
· Device
Terminated
Reference Electrode Membranes for use with blood gas analyzer ABL 800 FLEX, when used on ABL 827 and ABL 837 w...
Mar 5, 2010
· Device
Terminated
Waste bottles Part Numbers/Article Numbers: 905-590/D512 and 905-802/D513.
The waste bottles are used to coll...
Jul 15, 2009
· Device
Terminated
ABL7XX Calibration 1 Solution S1720. P/N S1720, 944-024
Intended for in vitro testing of samples of whole bl...
Dec 3, 2008
· Device
Terminated
ABL800 FLEX Series Analyzer - Human Blood Analyzer (Laboratory Device)
Jan 18, 2008
· Device
Terminated
ABL700 Series analyzer - Human Blood Analyzer (Laboratory Device).
Jan 18, 2008
· Device
Terminated
Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Fl...
Oct 11, 2007
· Device
Terminated
ABL 700 Series blood gas analyzers equipped with Software Version 3.833.
Jul 24, 2007
· Device
Terminated
ABL 800 FLEX series blood gas analyzers containing software version 5.24.
Jul 24, 2007
· Device
Terminated
SafeClinitubes, REF 942-892, D957P-70-100x1, contained in kits containing 250 SafeClinitubes, insert, mixing w...
Jul 3, 2007
· Device
Terminated
ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27
Apr 6, 2007
· Device
Terminated
Radiance Data Management System, Software Version 2.60, modification for the ABL800 Flex Blood Gas Analyzer
Oct 28, 2006
· Device
Terminated
D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous Oxyge...
Aug 31, 2006
· Device
Terminated
TC Monitor - Transcutaneous Monitor for p02 and pC02, Model #TCM4, (Cutaneous Oxygen Monitor)
Aug 30, 2006
· Device
Terminated
S1730 Calibration Solution 2, 200 mL, packed in single unit plastic bottles, REF 944-025, used with ABL700 Se...
Aug 29, 2006
· Device
Terminated
SafePICO Samplers, self-filling arterial blood samplers. The syringe blood samplers are individually packed i...
Aug 29, 2006
· Device
Terminated
TCM4 Series Monitoring System (Base Unit) 391-876 (affected device) CompactFlash cards: 914-698 (Defective Dev...
Aug 29, 2006
· Device
Terminated
D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of blood gas analyzers.
Aug 26, 2006
· Device
Terminated
SafeClinitubes, Capillary caps (purple), 905-787. The defective capillary caps may be included in capillary t...
Aug 26, 2006
· Device
Terminated
Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-700 Series, manufactured from 8/1998 through 11/...
Aug 10, 2006
· Device
Terminated
Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzers, ABL-800 series, manufactured from 8/2004 through 9/200...
Aug 10, 2006
· Device
Terminated
Capillary (end) caps, accessory for use with blood gas analyzers included in Radiometer''s CLINITUBES kits. Th...
Aug 3, 2006
· Device
Terminated
Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Numbers: 945-633, distributed one (...
Aug 3, 2006
· Device
Terminated
ABL 5 Capillary Adaptor (a connection that fits the capillary tube on to the aspirator on the ABL 5 & BPH 5 An...
Aug 3, 2006
· Device
Terminated
Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Number: 945-603, distributed one (1...
Aug 3, 2006
· Device
Terminated
Capillary (end) caps, accessory for use with blood gas analyzers included in Radiometer''s CLINITUBES kits. Th...
Aug 3, 2006
· Device
Terminated
ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21.
Aug 3, 2006
· Device
Terminated
Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-800 series.
Aug 2, 2006
· Device
Terminated
D711, Reference Membranes, Part #942-058, used with the ABL835 Blood Gas Analyzers.
Aug 2, 2006
· Device
Terminated
Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-700 series.
Aug 2, 2006
· Device
Terminated
Package Insert which accompanies the Hematocrit and Metabolite QUALICHECK LEVEL 2 Quality Control of Hematocri...
Aug 2, 2006
· Device
Terminated
D 744 Chloride membrane, CI, REF Model #942-061, accessory to the ABL700 blood analyzer.
Aug 1, 2006
· Device
Terminated
Radiance Data Management System Software Version 2.42 (Stand-alone software package) for the Radiance STAT Ana...
Jul 27, 2006
· Device
Terminated