Z-1051-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 25, 2017
- Initiation Date
- December 12, 2016
- Termination Date
- March 31, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32 Kits (320 individual disposable cartridges)
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.
Distribution Pattern
US Nationwide Distribution.
Code Information
Lot 1629103 Catalog Number: GBSIDR-10 Unique Device ldentifier (UDl): B1 78GBS|DR102