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Terminated

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

FDA Recall Z-1895-2020 · Posted None

Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product CodeJKD
Date Initiated2020-04-01
Date Terminated2020-09-01
Product Quantity65 kits total

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.

Firm Action

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.

Root Cause

Employee error

Distribution Pattern

International distributed only in Mexico, no US distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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