Devices

Device Recall ABL8O FLEX

Model / Serial
Software Version 1.10 Lot numbers: 17293, 17384, 17440, 17515, 17572 and 17663.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
In US to Cleveland, OH and Worldwide to Belgium, Denmark, France, Germany, The Netherlands, Sweden & United Kingdom
Product Description
ABL8O FLEX Software Version 1.10 included in the ABL8O Flex Analyzer, Model Number 914863
Manufacturer
Sendx Medical Inc
1 Event
- Recall of Device Recall ABL8O FLEX

Manufacturer

Sendx Medical Inc

Manufacturer Address
Sendx Medical Inc, 1945 Palomar Oaks Way, Carlsbad CA 92009-1307
Source
USFDA

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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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