Devices

Device Recall ADVIA Chemistry Enzyme 2 Calibrator

Model / Serial
Lots 6JD079 and 6MD042
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - United States Nationwide: Denmark Sweden Norway Great Britain Belgium Netherlands Spain Israel Switzerland France Portugal Greece Germany Slovenia Czech Republic Hong Kong Colombia Korea Australia
Product Description
ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture || Product Usage: || Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT_c, ALTP5P, ALTP_c, ASTP5P and ASTP_c
Manufacturer
Siemens Healthcare Diagnostics, Inc.
1 Event
- Recall of Device Recall ADVIA Chemistry Enzyme 2 Calibrator

Manufacturer

Siemens Healthcare Diagnostics, Inc.

Manufacturer Address
Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA

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