Device product
ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
Z-1895-2020
Product summary
- Event
- Event 85394
- Status
- Terminated
- Classification
- Class III
- Quantity
- 65 kits total
- Official record key
device-enforcement:Z-1895-2020
Official wording
Reason: 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.
Code information: Lot Numbers 01819G000, Exp Date 12JUN2020
Distribution pattern: International distributed only in Mexico, no US distribution.
Derived failure modes
-
Unknown
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.