Food, drugs, devices › Bayer Healthcare Llc
Device recall: Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated He
FDA enforcement event 66101 is a device recall by Bayer Healthcare Llc of Sunnyvale, CA, initiated 26 Aug 2013 and classified Class II, with 1 product record.
FDA defines Class II as 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. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 14 Jan 2014. Initiation: voluntary: firm initiated. Bayer Healthcare Llc has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Bayer Healthcare Llc, Sunnyvale, CA.
Reason for recall
"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."
Distribution
"Worldwide Distribution - USA (nationwide) and Internationally to China, Argentina, Uruguay, Japan."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0136-2014 | 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… | 138 Kits in US (Total 2452) | Class II | Terminated | 13 Nov 2013 |
Context
Other enforcement events for Bayer Healthcare Llc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 22 Jun 2015 | Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control solution. Plastic bottl | Device | Class II | 1 |
| 7 Dec 2012 | Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400 mg/Expectorant, a) 24 coated caple | Drug | Class III | 1 |
| 26 Apr 2012 | Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC, Distributed by Bayer Health Ca | Drug | Class III | 2 |
All 4 events for Bayer Healthcare Llc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - USA (nationwide) and Internationally to China, Argentina, Uruguay, Japan."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 14 Jan 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.