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 i…

Recall date

December 12, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1051-2017

FDA classification

Class II

Brand / firm

Great Basin Scientific, Inc.

Sold / distributed

US Nationwide Distribution.

Why it was recalled

The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a false positive.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.