FDA-Device2020-05-13Class III
ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
Abbott Laboratories
Hazard
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.
Sold states
International distributed only in Mexico, no US distribution.
Affected count
65 kits total
Manufactured in
100 Abbott Park Rd Bldg Ap8b, N/A, Abbott Park, IL, United States
Products
ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1893-2020Don't want to check this manually?
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