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Devices
Device Recall IMMULITE 2000/IMMULITE 2000 XPi Sex Hormone Binding Globulin
Model / Serial
Lot Numbers: 1) 357, 2) 358, 3) 360, 4) 361 & 5) 363 Expiration Dates: 1) 2017-01-30, 2) 2017-03-31, 3) 2017-04-30, 4) 2017-05-31 & 5) 2017-06-30
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
SHBG IMMULITE 2000/IMMULITE 2000 XPi || For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the quantitative measurement of SHBG in serum, as aid in the differential diagnosis of hirsutism.
Manufacturer
Siemens Healthcare Diagnostics, Inc.
1 Event
Recall of Device Recall IMMULITE 2000/IMMULITE 2000 XPi Sex Hormone Binding Globulin
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Manufacturer
Siemens Healthcare Diagnostics, Inc.
Manufacturer Address
Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA
Language
English
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