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Devices
Device Recall ABL800 Series analyzer with FLEXQ module
Model / Serial
There are no specific lot codes. (devices equipped with software version 5.2 to 5.27)
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution-USA including states of NY, KS, SD, OH, TX, KY, NC, IL, MO, AL, UT, CO, CA, NM, and MI and Country of Denmark
Product Description
ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27
Manufacturer
Radiometer America Inc
1 Event
Recall of Device Recall ABL800 Series analyzer with FLEXQ module
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Manufacturer
Radiometer America Inc
Manufacturer Address
Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1598
Source
USFDA
Language
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