TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
Reported: July 31, 2013 Initiated: June 20, 2013 #Z-1796-2013
Product Description
TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
Reason for Recall
Research Use Only (RUO) parameters were included in TEG 5000 User Manual.
Details
- Recalling Firm
- Haemonetics Corporation
- Units Affected
- 1590 devices
- Distribution
- US Nationwide
- Location
- Braintree, MA
Frequently Asked Questions
What product was recalled? ▼
TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies. Recalled by Haemonetics Corporation. Units affected: 1590 devices.
Why was this product recalled? ▼
Research Use Only (RUO) parameters were included in TEG 5000 User Manual.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 31, 2013. Severity: Moderate. Recall number: Z-1796-2013.
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