Devices

Device Recall Coagulation Factor VIII Deficient Plasma (OTXW)

Model / Serial
Lot numbers 503845A, 503846A, and 503847D
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
The product was shipped to medical facilities and laboratories in AR, AZ, CA, FL, GA, ID, IL, IN, KS, KY, MA, MD, NC, ND, NV, NY, OH, OK, PA, TX, VA, WA, WI, and WV. The products were also shipped to Germany, Belgium, Switzerland, Sweden, Netherlands, Russia, Spain, France, Italy, Portugal, Australia, Chile, China, Saudi Arabi, Taiwan, and Uraguay.
Product Description
Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test
Manufacturer
Dade Behring , Inc.
1 Event
- Recall of Device Recall Coagulation Factor VIII Deficient Plasma (OTXW)

Manufacturer

Dade Behring , Inc.

Manufacturer Address
Dade Behring , Inc., 500 GBC Dr., Mailstop 514, PO BOX 6101, Newark DE 19714-6101
Source
USFDA

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