# FDA recall Z-1304-2023

> **Instrumentation Laboratory** · Class II · device recall initiated 2023-02-03.

## Product

ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing.  Part Number: 0000880311

## Reason for recall

Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Albania, Algeria,  Australia, Austria, Azerbaijan, Belarus, Belgium, Brazil, Bulgaria, Cape Verde, China,  Colombia, Czech Republic, Egypt, Falkland Islands, Finland, France, Georgia, Germany,  Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Italy, Japan, Jordan,  Kazakhstan, Kenya, Kossovo, Latvia, Lebanon, Lithuania, Malawi, Malaysia, Mexico,  Philippines, Poland, Romania, Russian Fed., Saudi Arabia, Serbia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom,  Uruguay, Utd.Arab Emir., Vietnam, Zimbabwe.

## Key facts

- **Recall number:** Z-1304-2023
- **Recalling firm:** Instrumentation Laboratory
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-03
- **Report date:** 2023-04-05

- **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-1304-2023

## Citation

> AI Analytics. FDA recall Z-1304-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1304-2023. Source: US FDA. Licensed CC0.

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