Reported Jan 25, 2017 · Terminated
Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex…
Great Basin Scientific, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Great Basin Scientific, Inc. · 2441 S 3850 W · Salt Lake City, UT · 84120-7209
Is this the product you have?
- 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.
- Lot codes and dates
- Lot 1629103 Catalog NumberGBSIDR-10
- Unique Device ldentifier (UDl)B1 78GBS|DR102
- Amount recalled
- 32 Kits (320 individual disposable cartridges)
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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