Bayer A1CNow+ Test Kits Recalled for Potential Inaccurate Results
Bayer is recalling A1CNow+ test kits because they may produce high-bias readings if stored at room temperature for 4 to 5 months.
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 2/5 (Moderate).
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. The hazard involves potential inaccurate test results (high-bias) rather than direct physical injury or contamination, fitting the criteria for moderate severity.
Plain-English summary
Bayer HealthCare LLC is recalling specific lots of A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS. The recall involves 138 kits in the United States and 2,452 units worldwide. The affected lots were distributed in the US, China, Argentina, Uruguay, and Japan.
The recall is due to a potential accuracy issue. Test results from these specific lots may produce a high-bias reading of up to 20% if the product is stored at room temperature for four to five months after release. This bias is outside the limits defined for stability and product accuracy.
The A1CNow+ test is used for professional use to monitor glycemic control in people with diabetes by measuring glycated hemoglobin levels. Users should check their lot numbers against the recall notice and contact Bayer for instructions on how to proceed.
The recalled product
- Product
- Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by Bayer HealthCare LLC, Sunnyvale, CA The A1CNow+ test provides quantitative measurement of…
- Manufacturer
- Bayer Healthcare Llc
- Hazard
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 (6)
- Lot: 1300733 (US
- China)
- Lot: 1300712 (Argentina
- Uruguay)
- Lots: 1300711
- 130012 (Japan)
Distribution
Distributed nationwide across the United States.
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