Abbott HbA1c Calibrators Recalled for Potential Incorrect Value Sheets
Abbott Laboratories is recalling HbA1c Calibrators that may contain value sheets for a different lot, which could cause falsely elevated test results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a labeling error (incorrect value sheet) that leads to inaccurate test results rather than direct physical injury or contamination, fitting the criteria for moderate severity.
Plain-English summary
Abbott Laboratories is recalling 183 kits of HbA1c Calibrators LN 4P52-02, lot 45063UQ12. These calibrators are used to calibrate the Hemoglobin A1c assay on the ARCHITECT c 8000 and c 4000 Systems. The affected units were distributed worldwide in Austria, Canada, Cyprus, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Italy, Kuwait, Malaysia, Norway, Poland, Romania, Russia, Saudi Arabia, Thailand, Turkey, and the United Arab Emirates.
The recall was initiated because the kits may contain a value sheet intended for a different HbA1c calibrator lot. If the calibrator lot 45063UQ12 is used with values from an incorrect value sheet, all resulting Hemoglobin A1c assay results, including quality control and patient samples, may be falsely elevated.
Healthcare facilities and laboratories should stop using the affected calibrator kits and contact Abbott Laboratories for further instructions. The affected product has an expiration date of 15 DEC 2014.
The recalled product
- Product
- 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: O
- Manufacturer
- Abbott Laboratories
- Affected units
- 183
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- List Number: 4P52-02
- Lot Number: 45063UQ12
- Expiration Date: 15 DEC 2014
Distribution
Distribution scope not specified by the agency.
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