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Devices
Device Recall StatSampler
Model / Serial
Lot number: 7296 Expiration Date: 12/09; Lot 8031 Expiration Date: 3/10
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution --- USA including states of CA, CO, FL, KY, KS, GA, NC, NJ, OR, PA, and countries of Canada, Hong Kong, UK.
Product Description
StatSampler 200 uL, Li Heparin (micro blood collector) || Ref: SS2H || Packed in Catalog Numbers: || SS2H (I vial), SS2H-06 (6 kits/case), CH2C-I0 (I0 vials/kit) || Intended for collection and processing of capillary blood to prepare plasma/serum.
Manufacturer
StatSpin, Inc., dba Iris Sample Processing
1 Event
Recall of Device Recall StatSampler
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Manufacturer
StatSpin, Inc., dba Iris Sample Processing
Manufacturer Address
StatSpin, Inc., dba Iris Sample Processing, 60 Glacier Dr, Westwood MA 02090-1800
Manufacturer Parent Company (2017)
Danaher Corporation
Source
USFDA
Language
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