FDA-Device2017-01-25Class II
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
Great Basin Scientific, Inc.
Hazard
The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a false positive.
Sold states
US Nationwide Distribution.
Affected count
32 Kits (320 individual disposable cartridges)
Manufactured in
2441 S 3850 W, Salt Lake City, UT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1051-2017Don't want to check this manually?
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