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

Recall Z-2681-2014 — The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. BC-GN is perfor

U.S. FDA — Device Enforcement · United States · 2013-10-10 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2681-2014
Date of alert: 2013-10-10
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Nanosphere, Inc.
Product category: device
Product type: Devices

Reported risk: Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays.

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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