FDAClass IIJanuary 25, 2017

Great Basin Staph lD/R Blood Culture Panel The Great recall

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…

Why was Great Basin Staph lD/R Blood Culture Panel The Great recalled?

The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a false positive.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 1629103 Catalog Number: GBSIDR-10 Unique Device ldentifier (UDl): B1 78GBS|DR102

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…
Recalling firm
Great Basin Scientific, Inc.
Quantity
32 Kits (320 individual disposable cartridges)
Distribution
US Nationwide Distribution.
Recall date
January 25, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls