Z-2775-2016 Class II Terminated
FDA device recall Z-2775-2016 was initiated by Thermo Finnigan LLC on July 19, 2016 and is designated Class II. Reason for recall: Thermo Fisher has determined that the Endura MD mass spectrometer instrument control software versions 1.0 and 1.0 SP! have a software defect which affect data accuracy. The recall status is terminated (terminated February 21, 2017). Affected quantity: 6 (5 in Us distribuion and 1 in Japan).
Recall Details
- Product Type
- Devices
- Report Date
- September 21, 2016
- Initiation Date
- July 19, 2016
- Termination Date
- February 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 (5 in Us distribuion and 1 in Japan)
Product Description
Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body. Chemistry: In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body.
Reason for Recall
Thermo Fisher has determined that the Endura MD mass spectrometer instrument control software versions 1.0 and 1.0 SP! have a software defect which affect data accuracy.
Distribution Pattern
Worldwide distribution - US including FL, NY and Internationally to Japan.
Code Information
TQH-MD-E0101, THQ-MD-E-0102, TQH-MD-E0103, TQH-MD-E0104, TQH-MD-EMP003, TQH-MD-EMP-002.