Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnostic assay intended for use with the P4500 PortraitrM Analyzer System. The Staph lD/R Blood Culture Panel is capable of simultaneous detection and identification ol Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensrs and various Staphylococcus species to the genus level and the detection of the mecA gene for methicillin resistance from patient positive blood culture specimens.
Enforcement
- Recall Number
- Z-1051-2017
- Event ID
- 76076
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Great Basin Scientific, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- January 25, 2017
- Initiation Date
- December 12, 2016
- Classification Date
- January 19, 2017
- Termination Date
- March 31, 2017
- Address
- 2441 S 3850 W, Salt Lake City, UT, 84120-7209, United States
Description
Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnostic assay intended for use with the P4500 PortraitrM Analyzer System. The Staph lD/R Blood Culture Panel is capable of simultaneous detection and identification ol Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensrs and various Staphylococcus species to the genus level and the detection of the mecA gene for methicillin resistance from patient positive blood culture specimens.
The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a false positive.
Lot 1629103 Catalog Number: GBSIDR-10 Unique Device ldentifier (UDl): B1 78GBS|DR102
US Nationwide Distribution.
32 Kits (320 individual disposable cartridges)