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U.S. Department of Health and Human Services

Class 3 Device Recall Coagulation Factor VIII Deficient Plasma (OTXW)

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 Class 3 Device Recall Coagulation Factor VIII Deficient Plasma (OTXW)see related information
Date Initiated by FirmJuly 08, 2005
Date PostedAugust 16, 2005
Recall Status1 Terminated 3 on August 10, 2006
Recall NumberZ-1374-05
Recall Event ID 32691
510(K)NumberK924396 
Product Classification Plasma, Coagulation Factor Deficient - Product Code GJT
ProductCoagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test
Code Information Lot numbers 503845A, 503846A, and 503847D
Recalling Firm/
Manufacturer		 Dade Behring , Inc.
500 GBC Dr., Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information ContactRebecca S. Ayash
302-631-6276
Manufacturer Reason
for Recall		sample may exhibit falsely high results
FDA Determined
Cause 2		Other
ActionOn 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.
Quantity in Commerce3255 packs
DistributionThe 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GJT
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