Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1894-2020 — ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.

U.S. FDA — Device Enforcement · United States · 2020-04-01 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1894-2020
Date of alert
2020-04-01
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Abbott Laboratories
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.