TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
FDA Recall Z-1796-2013 · Posted 2013-07-24
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Recalling FirmHaemonetics Corporation
Recall StatusTerminated
Product CodeJPA
Date Initiated2013-06-20
Date Terminated2015-06-04
Product Quantity1590 devices
Reason for Recall
Research Use Only (RUO) parameters were included in TEG 5000 User Manual.
Firm 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.
Root Cause
Labeling False and Misleading
Distribution Pattern
US Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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