Abbott Laboratories: Medical Device Recall in 2014 - (Recall #: Z-0135-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (lyophilized) contain hemoglobin and glycated hemoglobin from human whole blood. Prior to lyophilization, the calibrator matrix is an MES-buffered solution. Preservative: Ofloxacin. For use in the calibration of the Hemoglobin A1c assay on the ARCHITECT c 8000 and c 4000 Systems.

Product Classification:

Class II

Date Initiated: April 30, 2014

Date Posted: November 5, 2014

Recall Number: Z-0135-2015

Event ID: 68201

Reason for Recall:

HbA1c Calibrators LN 4P52-02, lot 45063UQ12 may contain a value sheet for a different HbA1c calibrator lot. If calibrator lot 45063UQ12 is used in the calibration of the HbA1c assay using values from an incorrect calibrator value sheet then all results, including quality control and patient, may be falsely elevated.

Status: Terminated

Product Quantity: 183 calibrator kits

Code Information:

List Number: 4P52-02; Lot Number: 45063UQ12; Expiration Date: 15 DEC 2014

Distribution Pattern:

Worldwide Distribution in the countries of Austria, Canada, Cyprus, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Italy, Kuwait, Malaysia, Norway, Poland, Romania, Russia, Saudi Arabia, Thailand, Turkey, and United Arab Emirates.

Voluntary or Mandated:

Voluntary: Firm initiated