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U.S. Department of Health and Human Services

Class 3 Device Recall CoagAMate

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  Class 3 Device Recall CoagAMate see related information
Date Initiated by Firm September 29, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 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
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 2		 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.
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