Recall Z-2236-2014 ยท PEN Gram-Negative Bacteria And Associated Resistance Markers
Nanosphere, Inc.
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 th
| Date | Aug 14, 2014 (initiated Jul 9, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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-ma |
| Quantity | 1045 extraction trays (840 affected by recall) |
| Distribution | Nationwide Distribution including CA, CO, IA, MT, OH, OK, OR, TX, and UT |
| 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 |