Recall Z-1617-2020 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Haemonetics Corporation
TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagulation studies
| Date | Feb 19, 2020 |
| Status | Terminated |
| Reason | Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to this defect, reference range values received from TEG 5000 and displayed on the TEG Manager test result screen are rounded to the nearest whole number and lead to TEG Manager displaying an out of range alert when the test result is actually in range, or vice versa. |
| Root cause | Software design |
| Action | Haemonetics sent US customers using a TEG 5000 device and TEG Manager software a customer letter via email on February 19, 2020. This customer letter notified end users that Haemonetics is conducting a voluntary correction of all TEG Manager software used in conjunction with the TEG 5000 device. Letter states reason for recall, health risk and action to take: Haemonetics is developing a patch to correct the issue with the TEG Manager software. The patch is expected to be available in March of 2020. Haemonetics will contact customers when the TEG Manager software patch is available for downlo |
| Quantity | 88 units |
| Distribution | US Nationwide distribution. |
| 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 |