Recall Z-1051-2017— Great Basin Scientific, Inc.
Class II · Terminated
Class II FDA medical device recall by Great Basin Scientific, Inc., initiated 2016-12-12, terminated 2017-03-31. It names one FDA 510(k) clearance: K152470. 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.. Reason: The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a false positive..
- Recalling firm
- Great Basin Scientific, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-12-12
- Terminated
- 2017-03-31
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.