# FDA recall Z-0938-2026

> **Instrumentation Laboratory** · Class III · device recall initiated 2025-11-18.

## Product

HemosIL SynthAFax. Partial Thromboplastin Time Tests.

## Reason for recall

Recalled lots were manufactured with double the amount of preservative concentration.

## Distribution

Domestic: CA, CO, FL, NY; Foreign: AR, AT, CA, CZ, DE, DK, ES, FR, GB, IE, IL, IN, IT, JP, LK, NL, PL, PT, RO, RS, TH, VN.

## Key facts

- **Recall number:** Z-0938-2026
- **Recalling firm:** Instrumentation Laboratory
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-18
- **Report date:** 2025-12-24

- **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-0938-2026

## Citation

> AI Analytics. FDA recall Z-0938-2026. Retrieved 2026-08-23 from https://api.ai-analytics.org/recall/Z-0938-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*