FDAFDA · Alimentos y medicamentos·N.º oficial 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 %A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is for professional use to monitor glycemic control in people with diabetes.
Publicado el 13 de noviembre de 2013 · Inicio del retiro: 26 de agosto de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Bayer Healthcare Llc
- Distribuidor
- Worldwide Distribution - USA (nationwide) and Internationally to China, Argentina, Uruguay, Japan.
- Lote
- Lot: 1300733 (US, China); Lot: 1300712 (Argentina, Uruguay); Lots: 1300711, 130012 (Japan)
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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