Class 3 Device Recall CoagAMate

• Date Initiated by Firm: September 29, 2003
• Date Posted: July 20, 2004
• Recall Status: Terminated on June 08, 2005
• Recall Number: Z-0771-04
• Recall Event ID: 28595
• Product Classification: Instrument, Coagulation, Automated - Product Code GKP
• Product: Coag-A-Mate MTX and MTX II Instrument Operator Manual
• Code Information: All Codes
• FEI Number: 1039284
• Recalling Firm/ Manufacturer: Biomerieux, Inc.; 100 Rodolphe St; Durham NC 27712-9402
• For Additional Information Contact: bioMerieux Local Customer Representative; 919-920-2968
• Manufacturer Reason for Recall: Typographical error in the Operator Manual. In Chapter 11 of the MTX/MTX II Operator Manual, the numerical range for the Warning Flag is shown as 00-99. The correct numerical range is 0-99. The 'list of error and warning' chart shows a numerical range representing the codes 00-9. The correct numerical range for the first ten error/warning codes are 0-9.
• FDA Determined Cause: Other
• Action: Consignees were notified by letter on September 29, 2003.
• Quantity in Commerce: unknown
• Distribution: Nationwide, Argentina, Australia, Austria, Belgium, Brazil, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Greece, HK, India, Italy, Ivory Coast, Japan, Korea, Mexico, Netherlands, N. Zealand, Norway, Poland, Portugal, Russia, Spain, Sweden, Switzerland, Turkey, UK.
• 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.