# FDA recall Z-2323-2025

> **Instrumentation Laboratory** · Class II · device recall initiated 2025-02-03.

## Product

HemosIL LMW Heparin Controls;  Part Number: 0020300200;

## Reason for recall

Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed with HemosIL Liquid Anti-Xa and HemosIL Heparin Calibrator. In some complaints, failure to pass QC resulted in patient testing delays.

## Distribution

Worldwide - US Nationwide and the countries of Algeria, Andorra, Argentina, Australia, Austria, Belarus, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, Germany, Gibraltar, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Kyrgyzstan, Lebanon, Lithuania, Macao, Malaysia, Mexico, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Vietnam.

## Key facts

- **Recall number:** Z-2323-2025
- **Recalling firm:** Instrumentation Laboratory
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-03
- **Report date:** 2025-08-20

- **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-2323-2025

## Citation

> AI Analytics. FDA recall Z-2323-2025. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-2323-2025. Source: US FDA. Licensed CC0.

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