# FDA recall Z-1310-2022

> **Haemonetics Corporation** · Class II · device recall initiated 2022-04-26.

## Product

TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034

## Reason for recall

Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comparison to the normal donor reference range, it could lead to misdiagnosis and incorrect treatment or failure to treat.

## Distribution

Domestic distribution US Nationwide.

## Key facts

- **Recall number:** Z-1310-2022
- **Recalling firm:** Haemonetics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-04-26
- **Report date:** 2022-07-06
- **Termination date:** 2024-03-15

- **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-1310-2022

## Citation

> AI Analytics. FDA recall Z-1310-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1310-2022. Source: US FDA. Licensed CC0.

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