FDAClass IIIMay 13, 2020

ARCHITECT C Peptide Calibrator - Product Usage: used as recall

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

Why was ARCHITECT C Peptide Calibrator - Product Usage: used as recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers 01819G000, Exp Date 12JUN2020

Product
ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including…
Recalling firm
Abbott Laboratories
Quantity
65 kits total
Distribution
International distributed only in Mexico, no US distribution.
Recall date
May 13, 2020
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls