# FDA recall Z-2401-2020

> **Abbott Gmbh & Co. KG** · Class II · device recall initiated 2020-05-12.

## Product

Alinity C, Processing Module.  Chemistry analyzer for in-vitro diagnostics.

## Reason for recall

There is a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase, Amylase, Creatine Kinase, and Gamma Glutamyl Transferase.

## Distribution

U.S. States: AR, CA, CO, FL, GA, KS, KY, LA, MD, MI, MN, MO, MS, NC, NJ, NY, OK, SC, SD, TN, TX, UT, VA, WI, PR    Worldwide distribution: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BERMUDA, BRAZIL, CANADA, CHILE, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAMAICA, JORDAN, KENYA, MALAYSAI, MEXICO, NEW CALEDONIA, NORWAY, OMAN, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, SAUDIA ARABIA, SERBIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UK, URUGUAY, and VIETNAM.

## Key facts

- **Recall number:** Z-2401-2020
- **Recalling firm:** Abbott Gmbh & Co. KG
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-05-12
- **Report date:** 2020-06-24
- **Termination date:** 2023-01-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wiesbaden, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2401-2020

## Citation

> AI Analytics. FDA recall Z-2401-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2401-2020. Source: US FDA. Licensed CC0.

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