Z-1051-2017Class II

Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is a qualitative...

Name: Z-1051-2017 Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is a qualitative...
Creator: Great Basin Scientific, Inc.
Published: 2016-12-12
License: https://open.fda.gov/license/

Great Basin Scientific, Inc. / initiated 2016-12-12 / Terminated / root cause: manufacturing process

FDA source

Great Basin Scientific, Inc. began a recall of 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... on 2016-12-12. FDA classified it as Class II and gives the reason as "The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a false positive". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1051-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-12
Posted: 2017-01-19
Terminated: 2017-03-31
Recalling firm: Great Basin Scientific, Inc.
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.
Product code: PAM Gram-Positive Bacteria And Their Resistance Markers
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.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: The firm, Great Basin Scientific, notified customers by phone beginning on December 12, 2016 and by email on December 14 and 15, 2016. The notifications described the product, problem and actions to be taken. The customers were instructed to cease using and immediately discard all affected cartridges, the firm will replace those cartridges as soon as possible; and respond to the email or call Direct: 385.219.4540 or Support Team 888.333.9763 or email: [email protected] with any questions or concerns.
Quantity in commerce: 32 Kits (320 individual disposable cartridges)
Distribution: US Nationwide Distribution.
Product codes and lots: Lot 1629103 Catalog Number: GBSIDR-10 Unique Device ldentifier (UDl): B1 78GBS|DR102

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1051-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1051-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-19

Product code PAM

K152470Class IIGreat Basin Staph ID/R Blood Culture PanelGreat Basin Scientific, Inc. / cleared 2016-03-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)