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Recall Observatory FDA recall evidence

Device 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.

Z-1893-2020

April 01, 2020

Class III

Product summary

Firm
Abbott Laboratories
Event
Event 85394
Status
Terminated
Classification
Class III
Quantity
65 kits total
Official record key
device-enforcement:Z-1893-2020

Official wording

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.

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

Distribution pattern: International distributed only in Mexico, no US distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.