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Recall Observatory FDA recall evidence

Device product

TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies

Z-1796-2013

June 20, 2013

Class II

Product summary

Firm
Haemonetics Corporation
Event
Event 65635
Status
Terminated
Classification
Class II
Quantity
1590 devices
Official record key
device-enforcement:Z-1796-2013

Official wording

Reason: Research Use Only (RUO) parameters were included in TEG 5000 User Manual.

Code information: Per recall strategy.

Distribution pattern: US Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Research Use Only (RUO) parameters were included in TEG 5000 User Manual.