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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76076

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
December 12, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Great Basin Scientific, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

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Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1051-2017
Recall number
Z-1051-2017
Initiated
December 12, 2016
Classification
Class II
Status
Terminated
Quantity
32 Kits (320 individual disposable cartridges)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a false positive.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

US Nationwide Distribution.