Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610) Recalled by Bayer Healthcare Llc Due to Test results from these lots may produce a...

Date: August 26, 2013
Company: Bayer Healthcare Llc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Bayer Healthcare Llc directly.

Affected Products

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 the percent of glycated hemoglobin (%HbA1c or %A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is for professional use to monitor glycemic control in people with diabetes.

Quantity: 138 Kits in US (Total 2452)

Why Was This Recalled?

Test results from these lots may produce a high-bias reading (by up to 20%) that is outside of limits defined for stability and product accuracy when product is stored at room temperature four (4) to five (5) months after release.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Bayer Healthcare Llc

Bayer Healthcare Llc has 1 total recall tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report