| ABL90 FLEX Analyzer REF 393090 UDI:05700693930909 recall (Z-2320-2019) | Radiometer America Inc | 2019-08-22 |
| AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Cata recall (Z-0899-2017) | Radiometer America Inc | 2016-12-22 |
| AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay an recall (Z-0748-2016) | Radiometer America Inc | 2016-02-03 |
| Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873. The Fixatio recall (Z-2417-2015) | Radiometer America Inc | 2015-08-19 |
| Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800 FLEX analyz recall (Z-1293-2015) | Radiometer America Inc | 2015-03-18 |
| ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH recall (Z-1046-2015) | Radiometer America Inc | 2015-02-09 |
| HemoCue Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for recall (Z-0873-2015) | Radiometer America Inc | 2014-12-24 |
| RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application f recall (Z-2597-2014) | Radiometer America Inc | 2014-09-06 |
| pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic o recall (Z-1075-2014) | Radiometer America Inc | 2014-02-24 |
| ABL90 FLEX Analyzer Radiometer Medical ApS, kandevej 21 Brnshj, Denmark A portable, automa recall (Z-0816-2014) | Radiometer America Inc | 2014-01-23 |
| pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2 m recall (Z-0713-2014) | Radiometer America Inc | 2014-01-10 |
| Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in recall (Z-2303-2013) | Radiometer America Inc | 2013-09-30 |
| TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, recall (Z-1930-2013) | Radiometer America Inc | 2013-08-08 |
| Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used recall (Z-0608-2013) | Radiometer America Inc | 2012-12-21 |
| The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the recall (Z-2162-2012) | Radiometer America Inc | 2012-08-08 |
| The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intend recall (Z-2163-2012) | Radiometer America Inc | 2012-08-08 |
| ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro test recall (Z-2164-2012) | Radiometer America Inc | 2012-08-08 |
| S1827 Crea Calibration solution 1, 944-135, Lot DV-02 Radiometer Medical, Bronshoj Denmark recall (Z-1008-2012) | Radiometer America Inc | 2012-02-13 |
| TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. Product Usage: The device recall (Z-0341-2012) | Radiometer America Inc | 2011-12-01 |
| Ca++ Membrane Units, Model #942-046, and Model #942-060 used on ABL505/555, EML105, ABL600 recall (Z-2571-2011) | Radiometer America Inc | 2011-06-16 |
| ABL90 FLEX Portable Blood Gas Analyzer System, Part Number: 393-090, 510 (k) #K092686. All recall (Z-2112-2011) | Radiometer America Inc | 2011-04-28 |
| ABL90 FLEX Blood Analyzer Part Number: 393-090. Intended for use by trained technologists, recall (Z-1011-2011) | Radiometer America Inc | 2011-02-02 |
| Reference Electrode Membranes for use with blood gas analyzer ABL 800 FLEX, when used on A recall (Z-1015-2010) | Radiometer America Inc | 2010-03-05 |
| Waste bottles Part Numbers/Article Numbers: 905-590/D512 and 905-802/D513. The waste bottl recall (Z-1554-2009) | Radiometer America Inc | 2009-07-15 |
| ABL7XX Calibration 1 Solution S1720. P/N S1720, 944-024 Intended for in vitro testing of s recall (Z-0457-2009) | Radiometer America Inc | 2008-12-03 |
| Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic ba recall (Z-0038-2008) | Radiometer America Inc | 2007-10-11 |
| ABL 700 Series blood gas analyzers equipped with Software Version 3.833. recall (Z-1094-2007) | Radiometer America Inc | 2007-07-24 |
| ABL 800 FLEX series blood gas analyzers containing software version 5.24. recall (Z-1095-2007) | Radiometer America Inc | 2007-07-24 |
| SafeClinitubes, REF 942-892, D957P-70-100x1, contained in kits containing 250 SafeClinitub recall (Z-0975-2007) | Radiometer America Inc | 2007-07-03 |
| ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27 recall (Z-0705-2007) | Radiometer America Inc | 2007-04-06 |
| Radiance Data Management System, Software Version 2.60, modification for the ABL800 Flex B recall (Z-0115-2007) | Radiometer America Inc | 2006-10-28 |
| D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Moni recall (Z-1436-06) | Radiometer America Inc | 2006-08-31 |
| TC Monitor - Transcutaneous Monitor for p02 and pC02, Model #TCM4, (Cutaneous Oxygen Monit recall (Z-1437-06) | Radiometer America Inc | 2006-08-30 |
| SafePICO Samplers, self-filling arterial blood samplers. The syringe blood samplers are in recall (Z-1443-06) | Radiometer America Inc | 2006-08-29 |
| TCM4 Series Monitoring System (Base Unit) 391-876 (affected device) CompactFlash cards: 91 recall (Z-1453-06) | Radiometer America Inc | 2006-08-29 |
| S1730 Calibration Solution 2, 200 mL, packed in single unit plastic bottles, REF 944-025, recall (Z-1460-06) | Radiometer America Inc | 2006-08-29 |
| D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of bl recall (Z-1406-06) | Radiometer America Inc | 2006-08-26 |
| SafeClinitubes, Capillary caps (purple), 905-787. The defective capillary caps may be incl recall (Z-1442-06) | Radiometer America Inc | 2006-08-26 |
| Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-700 Series, manufactured from recall (Z-1386-06) | Radiometer America Inc | 2006-08-10 |
| Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzers, ABL-800 series, manufactured from recall (Z-1387-06) | Radiometer America Inc | 2006-08-10 |
| ABL 5 Capillary Adaptor (a connection that fits the capillary tube on to the aspirator on recall (Z-1320-06) | Radiometer America Inc | 2006-08-03 |
| Capillary (end) caps, accessory for use with blood gas analyzers included in Radiometer''s recall (Z-1321-06) | Radiometer America Inc | 2006-08-03 |
| Capillary (end) caps, accessory for use with blood gas analyzers included in Radiometer''s recall (Z-1322-06) | Radiometer America Inc | 2006-08-03 |
| Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Number: 945-603, recall (Z-1323-06) | Radiometer America Inc | 2006-08-03 |
| Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Numbers: 945-633, recall (Z-1324-06) | Radiometer America Inc | 2006-08-03 |
| ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21. recall (Z-1325-06) | Radiometer America Inc | 2006-08-03 |
| Package Insert which accompanies the Hematocrit and Metabolite QUALICHECK LEVEL 2 Quality recall (Z-1316-06) | Radiometer America Inc | 2006-08-02 |
| Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-700 series. recall (Z-1317-06) | Radiometer America Inc | 2006-08-02 |
| Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-800 series. recall (Z-1318-06) | Radiometer America Inc | 2006-08-02 |
| D711, Reference Membranes, Part #942-058, used with the ABL835 Blood Gas Analyzers. recall (Z-1319-06) | Radiometer America Inc | 2006-08-02 |
| D 744 Chloride membrane, CI, REF Model #942-061, accessory to the ABL700 blood analyzer. recall (Z-1314-06) | Radiometer America Inc | 2006-08-01 |
| Dri-Tek BG-OX Cartridge, Model #D7120, Cat. #946-003 Cartridges used in the NPT7 Analyzer, recall (Z-1261-06) | Radiometer America Inc | 2006-07-27 |
| Radiance Data Management System Software Version 2.42 (Stand-alone software package) for t recall (Z-1262-06) | Radiometer America Inc | 2006-07-27 |
| Model #842-326 (pump tube for waste) & Model #842-327 (pump tube for solution), Waste Tubi recall (Z-1260-06) | Radiometer America Inc | 2006-07-26 |