ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
Reported: May 13, 2020 Initiated: April 1, 2020 #Z-1893-2020
Product Description
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.
Details
- Recalling Firm
- Abbott Laboratories
- Units Affected
- 65 kits total
- Distribution
- International distributed only in Mexico, no US distribution.
- Location
- Abbott Park, IL
Frequently Asked Questions
What product was recalled? ▼
ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.. Recalled by Abbott Laboratories. Units affected: 65 kits total.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 13, 2020. Severity: Low. Recall number: Z-1893-2020.
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