Class 2 Device Recall Heparin Test

• Date Initiated by Firm: June 07, 2004
• Date Posted: July 31, 2004
• Recall Status: Terminated 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: 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.