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U.S. Department of Health and Human Services

Class 2 Device Recall Heparin Test

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  Class 2 Device Recall Heparin Test see related information
Date Initiated by Firm June 07, 2004
Date Posted July 31, 2004
Recall Status1 Terminated 3 on January 06, 2005
Recall Number Z-1305-04
Recall Event ID 29345
Product Classification Assay, Heparin - Product Code KFF
Product Berichrom Heparin Reagent (OWLD11). The reagent is a component in a test kit.
Code Information Lots 541428, 541429, expiration date of Nov 2006
Recalling Firm/
Manufacturer
Dade Behring , Inc.
Rte 896, Glasgow Business Community
Newark DE 19702
For Additional Information Contact Donna A. Wolf
302-631-0384
Manufacturer Reason
for Recall
Customers have reported a high rate of instrument error flags and calibration issues when using affected reagent.
FDA Determined
Cause 2
Other
Action The recalling firm sent a recalling letter to the direct accounts informing them that the affected lots can not be used for heparin determinations. Direct account were instructed
Quantity in Commerce 781 kits
Distribution The heparin reagent, which is a component of a test kit, wasdistributed to direct accounts in the following states: AZ, CA, CO, FL, IA, IL, IN, KY, OH, MA, MD, MI, MN, NC, NE, NJ, NM, NY, PA,TN, TX, WI, WV. Further, there are foreign countries also affected in this recall action, as listed: Australia, Canada, France, Finland, Germany, Israel, Italy, Spain, United kingdom, Spain
Total Product Life Cycle TPLC 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.
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