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U.S. Department of Health and Human Services

Class 2 Device Recall Thromboelastograph Instrument

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 Class 2 Recall
Thromboelastograph Instrument
see related information
Date Posted July 24, 2013
Recall Status1 Open
Recall Number Z-1796-2013
Recall Event ID 65635
Premarket Notification
510(K) Number
K002177 
Product Classification System, Multipurpose For In Vitro Coagulation Studies - Product Code JPA
Product TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
Code Information Per recall strategy.
Recalling Firm/
Manufacturer
Haemonetics Corporation
400 Wood Road
Braintree, Massachusetts 02184-2412
Manufacturer Reason
for Recall
Research Use Only (RUO) parameters were included in TEG 5000 User Manual.
FDA Determined
Cause 2
MISBRANDING: Labeling False and Misleading
Action Haemonetics sent a Medical Device Correction letter dated June 20, 2013 to all affected customers. The letter identified the affected product, problem and action to be taken. The letter instructs customers to discard the current manuals and replace with revised manuals included with the Customer Notification Letter. A Consignee Response Form has been included with the letter, which is to be signed and returned for effectiveness purposes. Follow up will be made to customers who don't return the Response Form. For questions contact TEG Technical Support team at 1-800-438-2834.
Quantity in Commerce 1590 devices
Distribution US Nationwide
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JPA and Original Applicant = HAEMOSCOPE CORP.
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