Recall Z-2170-2014 ยท PEN Gram-Negative Bacteria And Associated Resistance Markers
Nanosphere, Inc.
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 m
| Date | Aug 8, 2014 (initiated Apr 17, 2014) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Under Investigation by firm |
| Action | 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 im |
| Quantity | 580 test cartridges |
| Distribution | US Distribution including the states of AZ, CA, FL, MN, MT, NE, NJ, NY, TX and WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132843 | VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN) Nanosphere, Inc., Jan 8, 2014 |