Recall Z-1895-2020— Abbott Laboratories
Class III · Terminated
Class III FDA medical device recall by Abbott Laboratories, initiated 2020-04-01, terminated 2020-09-01. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Abbott Laboratories
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2020-04-01
- Terminated
- 2020-09-01
- Firm location
- Abbott Park, IL, United States
Product 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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.