Devices

Device Recall ADVIA 1650 Chemistry System

Model / Serial
Part No. 073-A001; all Advia Chemistry System units and serial numbers are involved in this ''field correction'' as well as existing assay lots for CARB, PHNY, GENT and DIG.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide including USA and Puerto Rico.
Product Description
ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.
Manufacturer
Bayer Healthcare, LLC (Diagnostics Division)
1 Event
- Recall of Device Recall ADVIA 1650 Chemistry System

Manufacturer

Bayer Healthcare, LLC (Diagnostics Division)

Manufacturer Address
Bayer Healthcare, LLC (Diagnostics Division), 511 Benedict Avenue, Tarrytown NY 10591-5097
Source
USFDA

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