Device 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.
Z-1051-2017
Product summary
- Event
- Event 76076
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32 Kits (320 individual disposable cartridges)
- Official record key
device-enforcement:Z-1051-2017
Official wording
Reason: The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a false positive.
Code information: Lot 1629103 Catalog Number: GBSIDR-10 Unique Device ldentifier (UDl): B1 78GBS|DR102
Distribution pattern: US Nationwide Distribution.
Derived failure modes
-
Unknown
The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a false positive.