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Devices
Device Recall Roche COBAS INTEGRA IGGT
Model / Serial
Lots: 66160001; exp. 12/31/06; 66395101, exp. 2/28/07; 67306401, exp. 1/31/08; 66954901, exp. 5/31/07; 67589901, exp. 4/30/08 and 68049501, exp. 10/31/08.
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide.
Product Description
Roche IGGT COBAS INTEGRA Immunoglobulin G (Turbidimetric); Catalog no. 20766631322. in vitro diagnostic.
Manufacturer
Roche Diagnostics Corp.
1 Event
Recall of Device Recall Roche COBAS INTEGRA IGGT
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Manufacturer
Roche Diagnostics Corp.
Manufacturer Address
Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
Source
USFDA
Language
English
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