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Devices
Device Recall DispoSystem for BCT System
Model / Serial
Lot numbers 57295, 57304, 57400, 57463, 57504, 57562, 57579, 57601, 57674, 57685, 57755, 57819, 57820, and 57832
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
The product was shipped to medical facilities nationwide. The product was shipped to one government facility in TN.
Product Description
DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.
Manufacturer
Dade Behring , Inc.
1 Event
Recall of Device Recall DispoSystem for BCT System
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Manufacturer
Dade Behring , Inc.
Manufacturer Address
Dade Behring , Inc., Rte 896, Glasgow Business Community, Newark DE 19702
Source
USFDA
Language
English
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