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Crédits
Devices
Device Recall ADVIA 1650 Chemistry System
Modèle / numéro de série
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.
Classification du dispositif
Clinical Chemistry and Clinical Toxicology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Worldwide including USA and Puerto Rico.
Description du dispositif
ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.
Manufacturer
Bayer Healthcare, LLC (Diagnostics Division)
1 Event
Rappel de Device Recall ADVIA 1650 Chemistry System
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Fabricant
Bayer Healthcare, LLC (Diagnostics Division)
Adresse du fabricant
Bayer Healthcare, LLC (Diagnostics Division), 511 Benedict Avenue, Tarrytown NY 10591-5097
Source
USFDA
Language
English
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