Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Great Basin Staph lD/R Blood Culture Panel The Great Basin Recalled by Great Basin Scientific, Inc. Due to The Great Basin Staph ID/R Panel is being...

Date: December 12, 2016
Company: Great Basin Scientific, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Great Basin Scientific, Inc. directly.

Affected 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.

Quantity: 32 Kits (320 individual disposable cartridges)

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Great Basin Scientific, Inc.

Great Basin Scientific, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report