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Manufacturers
Siemens Healthcare Diagnostics Inc.
Manufacturer Address
Siemens Healthcare Diagnostics Inc., 5700 W 96th St, Los Angeles CA 90045-5544
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA
3 Events
Recall of Immulite 2000 CMV IgG, and Immulite 2500 CMV IgG
Recall of Immulite 2000 Rubella Quantitative IgG, Immulite 2500 Rubella IgG
Recall of Device Recall IMMULITE 2000/2500 Chemiluminescent Substrate
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3 devices in the database
Immulite 2000 CMV IgG, and Immulite 2500 CMV IgG
Model / Serial
Lot Number 150
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
Product Description
IMMULITE 2000 and IMMULITE 2500 || IgG/IgM Sample Diluent, Cat. No. L2IGZ2, Lot Number 150
Immulite 2000 Rubella Quantitative IgG, Immulite 2500 Rubella IgG
Model / Serial
Lot Number 150
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
Product Description
IMMULITE 2000 and IMMULITE 2500 || IgG/IgM Sample Diluent, Cat. No. L2IGZ2, Lot Number 150
Device Recall IMMULITE 2000/2500 Chemiluminescent Substrate
Model / Serial
Substrate lot L2SUBX 253 packed into Module L2SUBM 282 (EXP: 2010-07-31); Substrate lot L2SUBX 254 packed into Module L2SUBM 283 (EXP:2010-07-31); Substrate lot L2SUBX 255 packed into Module L2SUBM 284 (EXP: 2010-07-31); Substrate lot L2SUBX 256A packed into Module L2SUBM 288 (EXP:2010-08-31); Substrate lot L2SUBX 257A packed into Module L2SUBM 286 (EXP:2010-08-31); Substrate lot L2SUBX 258 packed into Module L2SUBM 285 (EXP: 2010-08-31); Substrate lot L2SUBX 259A packed into Module L2SUBM 287 (EXP: 2010-08-31).
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
IMMULITE 2000/2500 Chemiluminescent Substrate Module || For the use in the routine operation of the IMMULITE 2000 and IMMULITE 2500 Analyzer.
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Siemens Healthcare Diagnostics Inc.
Manufacturer Parent Company (2017)
Siemens Ag
Source
TDMDAT
Siemens Healthcare Diagnostics INC.
Manufacturer Parent Company (2017)
Siemens Ag
Source
NIDFSINVIMA
Siemens Healthcare Diagnostics Inc.
Manufacturer Parent Company (2017)
Siemens Ag
Source
NIDFSINVIMA
SIEMENS HEALTHCARE DIAGNOSTICS INC. || Importer: SIEMENS HEALTHCARE
Manufacturer Parent Company (2017)
Siemens Ag
Source
NIDFSINVIMA
SIEMENS HEALTHCARE DIAGNOSTICS INC. || Importer: SIEMENS HEALTHCARE COLOMBIA
Manufacturer Parent Company (2017)
Siemens Ag
Source
NIDFSINVIMA
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