---
title: "HemosIL SynthAFax. Partial Thromboplastin Time Tests. — FDA record Z-0938-2026 | Is It on Recall"
description: "Recalled lots were manufactured with double the amount of preservative concentration."
url: https://isitonrecall.com/recall/fda-device-z-0938-2026-hemosil-synthafax-partial-thromboplastin-time-tests/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# HemosIL SynthAFax. Partial Thromboplastin Time Tests. — FDA record Z-0938-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Nov 18, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: HemosIL SynthAFax. Partial Thromboplastin Time Tests.
- **Reason**: Recalled lots were manufactured with double the amount of preservative concentration.
- **Classification**: Class III
- **Recalling firm**: Instrumentation Laboratory
- **Quantity**: 4,506 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0938-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0938-2026%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Part No. 0020007400; UDI: 08426950087649; Lot No. (Exp. Date) N0542231(2026-06-30), N0250088(2027-04-30, N0452249 (2027-06-30). |

Match all identifying details in the current notice. A brand name alone is not enough.

## 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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Arkansas](https://isitonrecall.com/state/arkansas/)
- [California](https://isitonrecall.com/state/california/)
- [Colorado](https://isitonrecall.com/state/colorado/)
- [Delaware](https://isitonrecall.com/state/delaware/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Illinois](https://isitonrecall.com/state/illinois/)
- [Indiana](https://isitonrecall.com/state/indiana/)
- [New York](https://isitonrecall.com/state/new-york/)

## Dates in the source

- **Report date**: Dec 24, 2025
- **Recall initiation date**: Nov 18, 2025
- **Center classification date**: Dec 17, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0938-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Instrumentation Laboratory records](https://isitonrecall.com/brand/instrumentation-laboratory/)