Devices

Device Recall ABL90 FLEX Blood Analyzer

Model / Serial
S/N 393-090R0059N007, 393-090R0061N008 & 393-090R0061N009
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- USA, including states of MI, NJ, & PA and countries Australia, Austria, Belgium, Denmark, Finland, France, Germany, Indonesia, Italy, Japan, Kuwait, Malaysia, Netherlands, Norway, Poland, Russia, Spain, Sweden, Switzerland, United Arab Emirates & United Kingdom.
Product Description
ABL90 FLEX Blood Analyzer Part Number: 393-090. || Intended for use by trained technologists, nurses, physicians and therapists and for use in a laboratory environment, near patient or point-of-care setting. Also, Intended for in vitro testing of samples of heparinized whole blood.
Manufacturer
Radiometer America Inc
1 Event
- Recall of Device Recall ABL90 FLEX Blood Analyzer

Manufacturer

Radiometer America Inc

Manufacturer Address
Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145
Manufacturer Parent Company (2017)
Danaher Corporation
Source
USFDA

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