Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1051-2017 — 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

U.S. FDA — Device Enforcement · United States · 2016-12-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1051-2017
Date of alert: 2016-12-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Great Basin Scientific, Inc.
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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