FDA recall Z-1893-2020

Product

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

Reason for recall

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.

Distribution

International distributed only in Mexico, no US distribution.

Key facts

Status

Terminated

Initiation date

2020-04-01

Report date

2020-05-13

Termination date

2020-09-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Abbott Park, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1893-2020