Devices

Device Recall SmartCycler

Model / Serial
All units with software code version #s: PN950-0101, Rev 1.7 and PN950-0108, Rev 1.7a
Product Classification
Dental Devices
Device Class
Not Classified
Implanted device?
No
Distribution
The product was distributed nationally to 94 consignees directly to medical facilities and internationally to 25 consignees via distributors.
Product Description
SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler
Manufacturer
Cepheid
1 Event
- Recall of Device Recall SmartCycler

Manufacturer

Cepheid

Manufacturer Address
Cepheid, 904 E Caribbean Dr, Sunnyvale CA 94089-1189
Manufacturer Parent Company (2017)
Danaher Corporation
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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