ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
Recall
- Recall Number
- Z-1895-2020
- Event Number
- 85394
- Firm
- Abbott Laboratories
- FEI Number
- 1415939
- Product Code
- JKD
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- April 1, 2020
- Terminated
- September 1, 2020
- Address
- 100 Abbott Park Rd, Bldg Ap8b, Abbott Park, IL, 60064-3502
Description
ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
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.
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.
International distributed only in Mexico, no US distribution.
65 kits total