Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is

FDA device recall Z-2170-2014 · posted 2014-08-08 · Terminated

Recall details

Recalling firm

Nanosphere, Inc.

Reason for recall

Nanosphere has determined that a portion of BC-GN Test Cartridge Lot number 040214021A has an elevated risk for No Call results and False Negative results. The BC-GN Test Cartridge (20-006-021) is distributed as part of the Verigene BC-GN Test Kit (20-005-021), which is labeled as "IVD". Therefore, Nanosphere has initiated a voluntary recall to retrieve the following BC-GN Test Cartridges: Test Ca

Action taken

All customers were initially notified of the recall by telephone on April 17, 2014. The customers were instructed to quarantine and return all affected product to Nanosphere. Nanosphere sent an Voluntary Product Recall Notification letter dated April 17, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letters 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 can 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

580 test cartridges

Distribution

US Distribution including the states of AZ, CA, FL, MN, MT, NE, NJ, NY, TX and WI

Date initiated

2014-04-17

Date posted

2014-08-08

Date terminated

2016-03-14

Location

Northbrook, IL

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