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

Recall Z-2736-2014 — Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers.

U.S. FDA — Device Enforcement · United States · 2013-06-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2736-2014
Date of alert: 2013-06-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Nanosphere, Inc.
Product category: device
Product type: Devices

Reported risk: There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process SP Processing Error when used due to the Processor SP experiencing difficulty releasing the Tip to the final location in the Tip Assembly. The difficult releasing the Tip can result in a Processing Error and occasionally the Tip to be dropped into the Processor SP.

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

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