Nanosphere, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2735-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP 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.

Product Classification:

Class II

Date Initiated: June 17, 2013

Date Posted: October 8, 2014

Recall Number: Z-2735-2014

Event ID: 68014

Reason for Recall:

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.

Status: Terminated

Product Quantity: 1,660 extraction trays

Code Information:

Part Number: 20-009-018; Lot Numbers: 051713018B, 052413018C

Distribution Pattern:

Worldwide Distribution:US (Nationwide) including states of: AZ, CA, FL, IL, KY, MD, MN, MT, OH, PA, TN, TX, VA, WA, WI; and countries of: Belgium, China, and Saudi Arabia.

Voluntary or Mandated:

Voluntary: Firm initiated