TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
This recall has been terminated (originally issued July 24, 2013).
- Company
- Haemonetics Corporation
- Recall Initiated
- June 20, 2013
- Posted
- July 24, 2013
- Terminated
- June 4, 2015
- Recall Number
- Z-1796-2013
- Quantity
- 1590 devices
- Firm Location
- Braintree, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Research Use Only (RUO) parameters were included in TEG 5000 User Manual.
Distribution
US Nationwide
Lot / Code Info
Per recall strategy.
Root Cause
Labeling False and Misleading
Action Taken
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.