Abbott Recalls Hemoglobin A1c Calibrators Due to Potential Test Bias
Abbott Laboratories is recalling 198 kits of Hemoglobin A1c Calibrators because a manufacturing defect may cause biased patient test results outside a specific concentration range.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that can result in biased patient test results, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Abbott Laboratories is recalling 198 kits of Hemoglobin A1c Calibrators (Ref 4P52-01, Lot 54582UQ02) used for calibrating the Hemoglobin A1c assay on Architect systems. The recall was initiated because the calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot.
The manufacturer observed no impact to assay performance within the HbA1c concentration range of 5.33% to 6.87%. However, outside of this range, a bias of greater than 3% may be seen with patient results. This device failure can result in potentially negatively or positively biased patient test results. The firm is currently investigating the root cause.
The affected products were distributed worldwide, including in the United States and in Austria, Germany, Italy, South Africa, and Spain. Users should stop using the affected calibrators and contact Abbott Laboratories for further instructions.
The recalled product
- Product
- "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product Usage: use in the calibration of the Hemoglobin A1c assay.
- Manufacturer
- Abbott Laboratories
- Hazard
- Affected units
- 198
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 (1)
- List Number: 4P52-01 Lot Number: 54582UQ02
Distribution
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