Great Basin Staph ID/R Blood Culture Panel Recalled for False Positives
Great Basin Scientific is recalling the Staph ID/R Blood Culture Panel because the S. aureus probe could result in false positive results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical diagnostic device with a potential for false positive results, which poses a risk of harm through misdiagnosis or unnecessary treatment, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Great Basin Scientific, Inc. is recalling the Great Basin Staph ID/R Blood Culture Panel. This product is a qualitative, multiplex in vitro diagnostic assay intended for use with the P4500 Portrait Analyzer System. It is designed to detect and identify specific Staphylococcus species and the mecA gene for methicillin resistance from patient positive blood culture specimens.
The recall is being conducted because the S. aureus probe in the panel could potentially result in a false positive. The affected product consists of 32 kits containing 320 individual disposable cartridges. The specific lot number is 1629103, with catalog number GBSIDR-10 and Unique Device Identifier (UDI) B1 78GBS|DR102.
The product was distributed nationwide in the United States. Healthcare facilities and laboratories that have received this specific lot should stop using the product and contact Great Basin Scientific for instructions on return or replacement.
The recalled product
- 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…
- Manufacturer
- Great Basin Scientific, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 1629103 Catalog Number: GBSIDR-10 Unique Device ldentifier (UDl): B1 78GBS
- DR102
Distribution
Distributed nationwide across the United States.
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