Abbott Gmbh & Co. KG: Medical Device Recall in 2020 - (Recall #: Z-2401-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 12, 2020

Date Posted: June 24, 2020

Recall Number: Z-2401-2020

Event ID: 85686

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.

Status: Terminated

Product Quantity: 421 serial numbers

Code Information:

List Number: 03R67-01: All serial numbers

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated