# FDA recall Z-1095-2026

> **Instrumentation Laboratory** · Class II · device recall initiated 2025-12-11.

## Product

The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of  heparin therapy.

## Reason for recall

Potential for microbial contamination.

## Distribution

Worldwide - US Nationwide distribution in the states of CA, FL, IL, MN, MS, NE, OH, TX, WI and the countries of Belgium, Netherlands, Luxembourg, Switzerland, China, Hong Kong, Israel, Italy, South Korea, Lithuania, Macao, Malaysia, Philippines, Qatar, Romania, Turkey, Kosovo.

## Key facts

- **Recall number:** Z-1095-2026
- **Recalling firm:** Instrumentation Laboratory
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-11
- **Report date:** 2026-01-21

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1095-2026

## Citation

> AI Analytics. FDA recall Z-1095-2026. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-1095-2026. Source: US FDA. Licensed CC0.

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