Abbott Laboratories recalls ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal in…

Recall date

April 1, 2020

Source

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

Recall number

Z-1893-2020

FDA classification

Class III

Brand / firm

Abbott Laboratories

Sold / distributed

International distributed only in Mexico, no US distribution.

Why it was recalled

Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents, Calibrators and Controls are being recalled until a new license is obtained.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.