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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.
Manufacturer
Siemens Healthcare Diagnostics Inc.
1 Event
Recall of Device Recall IMMULITE 2000/2500 Chemiluminescent Substrate
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Manufacturer
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
Language
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