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Devices
Device Recall Roche Cortisol reagent
Model / Serial
Lots 17592001, exp. 10/31/07; 17502002, exp. 10/31/07; 17733201, exp. 2/29/08; and 17733202, exp. 2/29/08.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide.
Product Description
Roche Cortisol reagent for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010 and Modular E 170 analyzers; Catalog no. 11875116122. in vitro diagnostic.
Manufacturer
Roche Diagnostics Corp.
1 Event
Recall of Device Recall Roche Cortisol reagent
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Manufacturer
Roche Diagnostics Corp.
Manufacturer Address
Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46250-0416
Source
USFDA
Language
English
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