Devices

ABL800 series analysers

Model / Serial
Model: All with software versions 6.14 through to Version 6.18, Affected:
Manufacturer
Radiometer Medical ApS
1 Event
- Recall of ABL800 series analysers

Manufacturer

Radiometer Medical ApS

Manufacturer Parent Company (2017)
Danaher Corporation
Source
NZMMDSA

4 devices with a similar name

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Analyser, blood gas , pCO2 Membrane Box (D788), used on ABL700 and ABL800 series analysers

Model / Serial
R338 to R493; part 942-063, pCO2, D788 Membrane ............................ Update code from MHRA: Select one of the Quality Control products listed below to be used for pCO2 verification: Qualicheck3+: S7330 (Level 1) Autocheck3+: S7335 (Level 1) Please see the attachment
Product Description
Pco2 Membrane Box (D788), used on ABL700 and ABL800 series analysers
Manufacturer
Radiometer Medical

942-063 pCO2 Membrane Box (D788) used with ABL700 and ABL800 Series Analysers

Model / Serial
Manufacturer
Radiometer Limited

D788 pCO2 Membrane (catalogue number 942-063) used with Radiometer ABL700 and ABL800 series analy...

Model / Serial
D788 pCO2 Membrane (catalogue number 942-063) used with Radiometer ABL700 and ABL800 series analysers (An in vitro diagnostic medical device (IVD)
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Manufacturer
Radiometer Pacific Pty Ltd

Radiometer ABL800 Series Analysers (used with software version 3.1 MR5). An in vitro diagnostic m...

Model / Serial
Radiometer ABL800 Series Analysers (used with software version 3.1 MR5). An in vitro diagnostic medical device (IVD).All Serial Numbers connected to HIS/LIS or middleware Data Management systemARTG Number: 228382
Manufacturer
Radiometer Pacific Pty Ltd

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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