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
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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. |
Code Information |
Lot Numbers 01819G000, Exp Date 12JUN2020 |
Recalling Firm/ Manufacturer |
Abbott Laboratories 100 Abbott Park Rd Bldg Ap8b Abbott Park IL 60064-3502
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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 |
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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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