FDAFDA · Food and drugs·Recall number Z-0135-2015
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.
Published November 5, 2014 · Recall initiated: April 30, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Laboratories
- Distributor
- 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.
- Lot
- List Number: 4P52-02; Lot Number: 45063UQ12; Expiration Date: 15 DEC 2014
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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