UnratedMedical device recall · FDA · Published April 1, 2020
Abbott ARCHITECT C Peptide Calibrator Recall: Mexico License Error
Abbott recalls ARCHITECT C Peptide Calibrators due to Mexico license renewal documentation error. All units until new license is obtained are affected. No immediate action needed.
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.
Take action
Contact the company
📍Recalling firmAbbott Laboratories100 Abbott Park Rd Bldg Ap8b · Abbott Park, IL 60064-3502
“Abbott ARCHITECT C Peptide Calibrator Recall: Mexico License Error.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65585-abbott-architect-c-peptide-calibrator-recall-mexico-license-error. Based on FDA recall #Z-1894-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1894-2020%22&limit=1).
The FDA announced on April 1, 2020, that Abbott Laboratories is recalling ARCHITECT C Peptide Calibrators due to an error in the renewal documentation process for a license in Mexico. The company is recalling all in-date reagents, calibrators, and controls until a new license is obtained.
How to tell if you have it
Brand: Abbott
Product: ARCHITECT C Peptide Calibrator
Lot Number: 03619E000
Expiration Date: 08APR2020
The hazard
The recall is due to an error in the renewal documentation process for a license in Mexico. The ARCHITECT C Peptide Calibrator is used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion, including diabetes mellitus.
Context
GovInfoNow's records show Abbott Laboratories has 33 other recalls on record since May 14, 2012. Other recent recalls include a Class I recall for FreeStyle Libre 14 Day Sensors by Abbott Diabetes Care (Nov. 24, 2025) and a correction for the Alinity ci-series System Control Module (Nov. 13, 2025). Medline also issued recalls on Feb. 25, 2026, rescinding 510(k) clearances for Angiography Kits and Syringes.
How to tell if you have this one
Check for lot number 03619E000 with expiration date 08APR2020 on the ARCHITECT C Peptide Calibrator. The product is used for diabetes testing in patients with abnormal insulin secretion.
Brand
Abbott
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class III
Status
Terminated
Distribution
International distributed only in Mexico, no US distribution.
Recall number
Product, codes & lots
Z-1893-2020
ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.; Lot Numbers 01719F000 (Exp Date 14MAY2020), 02519E000 (Exp Date 09APR2020)
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.; Lot Numbers 03619E000, Exp Date 08APR2020
Z-1895-2020
ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.; Lot Numbers 01819G000, Exp Date 12JUN2020
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the lot number and expiration date on the calibrator to confirm if it's affected.
How this recall unfolded
Recall timeline
FDA terminated this recall 5 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1894-2020 (April 1, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1894-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.