Z-1895-2020Class III

ARCHITECT C Peptide Calibrator -

Name: Z-1895-2020 ARCHITECT C Peptide Calibrator -
Creator: Abbott Laboratories
Published: 2020-04-01
License: https://open.fda.gov/license/

Abbott Medical / initiated 2020-04-01 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories began a recall of ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes... on 2020-04-01. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1895-2020
Classification: Class III
Status: Terminated
Initiated: 2020-04-01
Posted: 2020-05-05
Terminated: 2020-09-01
Recalling firm: Abbott Medical
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.
Product code: JKD Radioimmunoassay, C-Peptides Of Proinsulin
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Lot Numbers 01819G000, Exp Date 12JUN2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1895-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1893-2020	Class III	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-05
Z-1894-2020	Class III	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-05
Z-1895-2020	Class III	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-05

Product code JKD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)