# FDA recall Z-0352-2024

> **Roche Diagnostics Operations, Inc.** · Class II · device recall initiated 2023-10-03.

## Product

Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503)

## Reason for recall

Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0352-2024
- **Recalling firm:** Roche Diagnostics Operations, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-03
- **Report date:** 2023-11-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indianapolis, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0352-2024

## Citation

> AI Analytics. FDA recall Z-0352-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0352-2024. Source: US FDA. Licensed CC0.

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