Nanosphere, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2236-2014)

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-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions, including wash solutions, oligonucleotide probe solution and signal amplification solutions required to generate a test result. BC-GN is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, is not used to monitor these infections.

Product Classification:

Class II

Date Initiated: July 9, 2014

Date Posted: August 20, 2014

Recall Number: Z-2236-2014

Event ID: 68831

Reason for Recall:

Nanosphere Inc. has recently determined through four customer complaints that a small number of Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) Extraction Trays in Lot 042914021B have low levels or are missing Magnetic Microparticles (MMPs) required for DNA Extraction.

Status: Terminated

Product Quantity: 1045 extraction trays (840 affected by recall)

Code Information:

VERIGENE BC-GN TEST KIT (Catalog Number: 20-005-021). TEST CARTRIDGES: Part Number: 20-006-021, Lot Number: 042914021B, Expiration Date: 10/26/14

Distribution Pattern:

Nationwide Distribution including CA, CO, IA, MT, OH, OK, OR, TX, and UT

Voluntary or Mandated:

Voluntary: Firm initiated