# FDA recall Z-0151-2022

> **Instrumentation Laboratory** · Class II · device recall initiated 2021-08-25.

## Product

HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACLTOP¿ Family, ACL TOP  Family 50 Seriest and ACL Elite¿/Elite Pro)  Part Number: 0020302601

## Reason for recall

Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days

## Distribution

US Nationwide    Foreign:  Canada  Armenia						  Austria						  Australia						  Belgium						  Brunei						  Brazil						  Belarus						  Switzerland						  China						  Colombia						  Czech Republic						  Germany						  Denmark						  Spain						  Finland						  France					  United Kingdom					  Gibraltar					  Greece					  Hong Kong					  Hungary					  Indonesia					  Ireland					  Israel					  India					  Iran					  Italy¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿					  Japan						  South Korea						  Kuwait						  Kazakhstan						  Lebanon						  Sri Lanka						  Lithuania						  Luxembourg						  Macau						  Mexico						  Malaysia						  Netherlands						  Poland						  Portugal						  Qatar						  Reunion						  Romania						  Serbia						  Russia						  Saudi Arabia						  Sweden						  Thailand						  Tunisia						  Turkey						  Taiwan						  Vietnam						  Zambia

## Key facts

- **Recall number:** Z-0151-2022
- **Recalling firm:** Instrumentation Laboratory
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-08-25
- **Report date:** 2021-10-27

- **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-0151-2022

## Citation

> AI Analytics. FDA recall Z-0151-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0151-2022. Source: US FDA. Licensed CC0.

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