Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R… — Class II medical device recall Z-1051-2017
Terminated recall by Great Basin Scientific, Inc., reported 2017-01-25, distributed nationwide. The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a f
| Recall number | Z-1051-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Great Basin Scientific, Inc., Salt Lake City, UT, United States |
| Recall initiated | 2016-12-12 |
| Classified | 2017-01-19 |
| Reported by FDA | 2017-01-25 |
| Terminated | 2017-03-31 |
| Distributed | Nationwide (US) |
| Pathogens | staphylococcus |
| Lot numbers | 1629103 |
| Model numbers | GBSIDR-10 |
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 for recall
The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a false positive.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1051-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.