Recall Z-1738-2011 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Haemoscope Division of Haemonetics Corp
TEG 5000 Thrombelastograph Hemostasis Analyzer System; a multipurpose system for in vitro coagulation studies; Haemonetics, Haemoscope Division, Niles, IL 60714; list number 07-022 a multipurpose system for in vitro coagulation studies
| Date | Mar 21, 2011 (initiated Jan 28, 2011) |
| Status | Terminated |
| Reason | Haemonetics has received a report of smoke from the unit with a power supply failure. |
| Root cause | Other |
| Action | Haemoscope sent letters to all of their U.S. accounts on January 24, 2011, via certified mail. The letters listed guidelines regarding proper use of the TEG 5000 System Power Supply to eliminate any potential risks such as electrical shorting or power supply damage. The information, which was printed in the letter, will also be available in an updated TEG User Manual soon to be released. A Caution label with installation instructions was included with the letter, to be applied to the back of the TEG unit. The accounts were requested to complete the enclosed acknowledgement form and fax it |
| Quantity | 1,155 units |
| Distribution | Nationwide Distribution including CA, FL, MD, PA, OH, SC, TN, TX, and VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002177 | THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES Haemoscope Corp., Sep 14, 2000 |