Dade Behring Inc. Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test
Brand
Dade Behring Inc.
Lot Codes / Batch Numbers
Lot numbers 503845A, 503846A, and 503847D
Products Sold
Lot numbers 503845A, 503846A, and 503847D
Dade Behring Inc. is recalling Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test due to sample may exhibit falsely high results. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
sample may exhibit falsely high results
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, AR, CA, FL, GA, ID, IL, IN, KS, KY, MD, MA, NV, NY, NC, ND, OH, OK, PA, TX, VA, WA, WV, WI
Page updated: Jan 10, 2026