ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
- Company
- Abbott Laboratories
- Recall Initiated
- April 1, 2020
- Terminated
- September 1, 2020
- Recall Number
- Z-1894-2020
- Quantity
- 65 kits total
- Firm Location
- Abbott Park, IL
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.
Lot / Code Info
Lot Numbers 03619E000, Exp Date 08APR2020
Root Cause
Employee error
Action Taken
Abbott Laboratories notified customers on about 04/01/2020 via Product Recall letter. Instructions included to discontinue use and destroy any inventory of ARCHITECT CPeptide Reagents, Calibrators and Controls listed in the table above according to laboratory procedures. Instructions also included to complete and return the Customer Reply Form and to notify customers if product is further distributed.
More recalls by Abbott Laboratories
Brand Name: CELL-DYN Ruby
Product Name: CELL-DYN Ruby
Model/Catalog Number: 08H67-01
Software Versio...
Apr 22, 2025
Brand Name: CELL-DYN Ruby
Product Name: CELL-DYN Ruby
Model/Catalog Number: 08H67-03
Software Versio...
Apr 22, 2025
Brand Name: CELL-DYN Ruby
Product Name: CELL-DYN Ruby
Model/Catalog Number: 08H67-10
Software Versio...
Apr 22, 2025