Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test
- Company
- Dade Behring Inc.
- Recall Initiated
- July 8, 2005
- Posted
- August 16, 2005
- Terminated
- August 10, 2006
- Recall Number
- Z-1374-05
- Quantity
- 3255 packs
- Firm Location
- Newark, DE
Reason for Recall
sample may exhibit falsely high results
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.
Lot / Code Info
Lot numbers 503845A, 503846A, and 503847D
Root Cause
Other
Action Taken
On 7/13/05, the recalling firm issued letters to their customers informing them of the problem and the need to discontinue use and to discard any remaining product.
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