Recall Z-1796-2013 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Haemonetics Corporation
TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
| Date | Jul 24, 2013 (initiated Jun 20, 2013) |
| Status | Terminated |
| Reason | Research Use Only (RUO) parameters were included in TEG 5000 User Manual. |
| Root cause | Labeling False and Misleading |
| 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. |
| Quantity | 1590 devices |
| Distribution | US Nationwide |
| 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 |