Z-0135-2015 Class II Terminated
FDA device recall Z-0135-2015 was initiated by Abbott Laboratories on Apr 30, 2014 and is designated Class II. 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… The recall status is terminated (terminated Dec 28, 2016). Affected quantity: 183 calibrator kits.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 5, 2014
- Initiation Date
- Apr 30, 2014
- Termination Date
- Dec 28, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 183 calibrator kits
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.
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.
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.
Code Information
List Number: 4P52-02; Lot Number: 45063UQ12; Expiration Date: 15 DEC 2014
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0135-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026