Reported May 13, 2020 · Terminated

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

Abbott Laboratories

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Abbott Laboratories · 100 Abbott Park Rd Bldg Ap8b · Abbott Park, IL · 60064-3502

Is this the product you have?

  • ARCHITECT
  • C Peptide Calibrator - Product Usageused as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus
Lot codes and dates
    • Lot Numbers 01819G000
    • Exp Date 12JUN2020
Amount recalled
65 kits total

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Why it was 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.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 1, 2020 · Data as of Sep 19, 5:28 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.