# FDA recall Z-2185-2021

> **Abbott Laboratories** · Class II · device recall initiated 2021-06-10.

## Product

REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161859

## Reason for recall

There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results

## Distribution

Worldwide distribution - US Nationwide distribution in the states of VA, UT, TX, TN, SD,PA, NY, ME, ID, CA and the countries of AFGHANISTAN, AUSTRALIA, AUSTRIA, BAHAMAS, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVI, CANADA, CAYMAN ISLANDS, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FAROE ISLAND, FINLAND, FRANCE, GERMANY, GREENLAND, Hong Kong, INDIA, IRELAND, ISRAEL, ITALY, KUWAIT, LITHUANIA, LUXEMBOURG, MEXICO, MONTENEGRO, NETHERLANDS, NORWAY, OMAN, PAKISTAN, PANAMA, PHILIPPINES, PORTUGAL, PR CHINA, REPUBLIC OF YEMEN, ROMANIA, RUSSIA, SAUDI ARABIA, SLOVAKIA, SLOVENIA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD & TOBAGO, UNITED KINGDOM, VIETNAM.

## Key facts

- **Recall number:** Z-2185-2021
- **Recalling firm:** Abbott Laboratories
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-06-10
- **Report date:** 2021-08-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irving, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2185-2021

## Citation

> AI Analytics. FDA recall Z-2185-2021. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-2185-2021. Source: US FDA. Licensed CC0.

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