TEG Manager software versions used in conjunction with TEG 5000 are 1 — Class II medical device recall Z-1617-2020
Terminated recall by Haemonetics Corporation, reported 2020-04-08, distributed nationwide. Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to this defect,
| Recall number | Z-1617-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Haemonetics Corporation, Boston, MA, United States |
| Recall initiated | 2020-02-19 |
| Classified | 2020-03-31 |
| Reported by FDA | 2020-04-08 |
| Terminated | 2021-06-21 |
| Distributed | Nationwide (US) |
| Quantity | 88 units |
| Reason classes | software |
Product
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1617-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.