Great Basin Scientific, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1051-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product 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.

Product Classification:

Class II

Date Initiated: December 12, 2016

Date Posted: January 25, 2017

Recall Number: Z-1051-2017

Event ID: 76076

Reason for Recall:

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

Status: Terminated

Product Quantity: 32 Kits (320 individual disposable cartridges)

Code Information:

Lot 1629103 Catalog Number: GBSIDR-10 Unique Device ldentifier (UDl): B1 78GBS|DR102

Distribution Pattern:

US Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated