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Great Basin Scientific, Inc. recalls Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex
Recalled January 25, 2017 · FDA recall Z-1051-2017 · Great Basin Scientific
Hazard
The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a false positive. · FDA Class II
Units
32 Kits (320 individual disposable cartridges)
Sold at
US Nationwide Distribution.
Description
The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a false positive.
Product
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.
Manufacturer(s)
Great Basin Scientific, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →