Devices

Device Recall OBSERVA

Model / Serial
Software version R.02.00.17
Product Classification
Immunology and Microbiology Devices
Device Class
1
Implanted device?
No
Distribution
WorldwideDistribution--Nationwide to medical centers. Government distribution was made to MN and CA, and military distribution was made to OK. Foreign distribution was made to Thailand, The Netherlands, Germany, Greece, Portugal, and France.
Product Description
OBSERVA R02 (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which are connected to BacT/ALERT 3D
Manufacturer
bioMerieux Inc
1 Event
- Recall of Device Recall OBSERVA

Manufacturer

bioMerieux Inc

Manufacturer Address
bioMerieux Inc, 595 Anglum Rd, Hazelwood MO 63042-2320
Source
USFDA

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Disclaimer

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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