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U.S. Department of Health and Human Services

Class 2 Device Recall Thromboelastograph Instrument

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 Class 2 Device Recall Thromboelastograph Instrumentsee related information
Date Initiated by FirmJune 20, 2013
Date PostedJuly 24, 2013
Recall Status1 Terminated 3 on June 04, 2015
Recall NumberZ-1796-2013
Recall Event ID 65635
510(K)NumberK002177 
Product Classification System, multipurpose for in vitro coagulation studies - Product Code JPA
ProductTEG 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 MA 02184-2412
For Additional Information Contact
781-848-7100
Manufacturer Reason
for Recall		Research Use Only (RUO) parameters were included in TEG 5000 User Manual.
FDA Determined
Cause 2		Labeling False and Misleading
ActionHaemonetics 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 Commerce1590 devices
DistributionUS Nationwide
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = JPA
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