Abbott Laboratories: Medical Device Recall in 2020 - (Recall #: Z-1894-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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 Classification:

Class III

Date Initiated: April 1, 2020

Date Posted: May 13, 2020

Recall Number: Z-1894-2020

Event ID: 85394

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.

Status: Terminated

Product Quantity: 65 kits total

Code Information:

Lot Numbers 03619E000, Exp Date 08APR2020

Distribution Pattern:

International distributed only in Mexico, no US distribution.

Voluntary or Mandated:

Voluntary: Firm initiated