Devices

Device Recall Bayer brand A1CNow MULTITEST A1C SYSTEM TEST KITS

Model / Serial
Lot: 1300733 (US, China); Lot: 1300712 (Argentina, Uruguay); Lots: 1300711, 130012 (Japan)
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to China, Argentina, Uruguay, Japan.
Product Description
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.
Manufacturer
Bayer Healthcare Llc
1 Event
- Recall of Device Recall Bayer brand A1CNow MULTITEST A1C SYSTEM TEST KITS

Manufacturer

Bayer Healthcare Llc

Manufacturer Address
Bayer Healthcare Llc, 510 Oakmead Pkwy, Sunnyvale CA 94085-4022
Manufacturer Parent Company (2017)
Bayer AG
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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