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U.S. Department of Health and Human Services

Class 3 Device Recall ARCHITECT CPeptide Calibrator

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  Class 3 Device Recall ARCHITECT CPeptide Calibrator see related information
Date Initiated by Firm April 01, 2020
Create Date May 05, 2020
Recall Status1 Terminated 3 on September 01, 2020
Recall Number Z-1895-2020
Recall Event ID 85394
Product Classification Radioimmunoassay, c-peptides of proinsulin - Product Code JKD
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.
Code Information Lot Numbers 01819G000, Exp Date 12JUN2020
Recalling Firm/
Manufacturer		 Abbott Laboratories
100 Abbott Park Rd Bldg Ap8b
Abbott Park IL 60064-3502
For Additional Information Contact Albert Chianello
224-668-5781
Manufacturer 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.
FDA Determined
Cause 2		 Employee error
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.
Quantity in Commerce 65 kits total
Distribution International distributed only in Mexico, no US distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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