# FDA recall Z-1617-2020

> **Haemonetics Corporation** · Class II · device recall initiated 2020-02-19.

## 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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1617-2020
- **Recalling firm:** Haemonetics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-19
- **Report date:** 2020-04-08
- **Termination date:** 2021-06-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Boston, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1617-2020

## Citation

> AI Analytics. FDA recall Z-1617-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1617-2020. Source: US FDA. Licensed CC0.

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