# FDA recall Z-2681-2024

> **Abbott Laboratories** · Class II · device recall initiated 2024-06-14.

## Product

Alinity hq Analyzer, REF: 09P68-01

## Reason for recall

1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following on same rack CBC+Diff sample is run, then falsely low red blood cell count may occur, generating falsely high Mean Cell Hemoglobin(MCH)/MCHC and falsely low hematocrit results. 2)Cell events may be incorrectly counted as basophil(BASO), resulting in increased BASO and %BASO counts

## Distribution

Worldwide - US Nationwide distribution in the states of NY, OK, NC and the countries of  ALBANIA, ARGENTINA, AUSTRALIA, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, Botswana, BRAZIL, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FRANCE, GERMANY, GREECE, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, ITALY, JAMAICA, JAPAN, JORDAN, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MALDIVES, MEXICO, NETHERLANDS, NORWAY, OMAN, PAKISTAN, PANAMA, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, SAUDI ARABIA, SERBIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWITZERLAND, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UK, URUGUAY, VIETNAM.

## Key facts

- **Recall number:** Z-2681-2024
- **Recalling firm:** Abbott Laboratories
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-06-14
- **Report date:** 2024-08-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Clara, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2681-2024

## Citation

> AI Analytics. FDA recall Z-2681-2024. Retrieved 2026-09-08 from https://api.ai-analytics.org/recall/Z-2681-2024. Source: US FDA. Licensed CC0.

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