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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Device

Abbott Laboratories: 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.

Agency Publication Date: May 5, 2020
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Affected Products

Product: ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.

Lot Numbers 01719F000 (Exp Date 14MAY2020), 02519E000 (Exp Date 09APR2020)

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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.

Lot Numbers 03619E000, Exp Date 08APR2020

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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.

Lot Numbers 01819G000, Exp Date 12JUN2020

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Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85394
Status: Resolved
Manufacturer: Abbott Laboratories
Manufactured In: United States
Units Affected: 3 products (65 kits total)

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.