Verigene Gram-Negative Blood Culture Nucleic Acid Test… recallZ-2170-2014 · Nanosphere, Inc. · initiated Apr 17, 2014

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

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 [email protected]..

Recall details

Recall number

Z-2170-2014

Recall class

Class II

Status

Terminated

Initiated by the company

Apr 17, 2014

Posted by the FDA

Aug 8, 2014

Recalling firm

Nanosphere, Inc.

Quantity

580 test cartridges

Product code

PEN

FDA submissions

K132843

Distribution

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

Product description

Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. BC-GN is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-negative bacteria as determined by gram stain. 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. Sub-culturing of positive blood cultures is necessary to recover organisms for antimicrobial susceptibility testing (AST), for identification of organisms not detected by BC-GN, to detect mixed infections that may not be detected by BC-GN, for association of antimicrobial resistance marker genes to a specific organisms, or for epidemiological typing. The BC-GN test is performed on the Verigene System platform, which is a fully automated, bench-top, molecular diagnostics workstation consisting of Verigene Reader and a bank of up to 32 Verigene Processor SP units. The System enables the detection of bacterial DNA from blood culture, unformed stool, or nasopharyngeal swab, depending on the test, through automated nucleic acid extraction and hybridization.

Other devices under the same FDA submission

3 devices cleared under K132843 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• Gram-Negative Blood Culture (BC-GN) Nucleic Acid Test Cartridge 20-006-021

  Luminex Corporation · Gram-Negative bacteria and associated resistance markers
  1 recall1 death15 reports
• Gram-Negative Blood Culture (BC-GN) Nucleic Acid Test Cartridge 20-006-021

  Nanosphere, Inc. · Gram-Negative Bacteria And Associated Resistance Markers
  2 deaths2 reports
• Gram-Negative Blood Culture (BC-GN) Utility Tray 20-011-021

  Luminex Corporation · Gram-Negative bacteria and associated resistance markers
  1 report