Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge

FDA device recall Z-2236-2014 · posted 2014-08-14 · Terminated

Recall details

Recalling firm

Nanosphere, Inc.

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.

Action taken

Nanosphere sent an Urgent Product Recall letter dated July 9, 2014 to all affected customers. All customers were initially notified of the recall by telephone on July 9, 2014. The customers were instructed to quarantine and return all affected product to Nanosphere. The letter included instructions: 1) on how to return the recalled products, and 2) to review any test results that were generated while using the recalled products to ensure that there has been no negative impact on patient care. Customers with questions were instructed to contact Nanosphere at 888-837-4436, option 2 or via e-mail at Technicalsupport@nanosphere.us.

Root cause

Under Investigation by firm

Status

Terminated

Product code

PEN

Quantity affected

1045 extraction trays (840 affected by recall)

Distribution

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

Date initiated

2014-07-09

Date posted

2014-08-14

Date terminated

2015-09-01

Location

Northbrook, IL

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