Abbott Gmbh & Co. KG recalls Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.

Recall date

May 12, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2401-2020

FDA classification

Class II

Brand / firm

Abbott Gmbh & Co. KG

Sold / distributed

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,…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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