Recall Z-2683-2014 ยท PAM Gram-Positive Bacteria And Their Resistance Markers
Nanosphere, Inc.
The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). BC-UP is performed directly on blood culture bottles identified as positive by a
| Date | Sep 23, 2014 (initiated Oct 10, 2013) |
| Status | Terminated |
| Reason | Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays. |
| Root cause | Nonconforming Material/Component |
| Action | Nanosphere sent a Field Notification Letter dated October 10, 2013, to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. Instructions were included in the letter for customers to determine whether or not the extraction tray lots should be returned. If the extraction tray lots are to be returned, customers were to complete and return the attached form and replacement tip holder assemblies will be supplied at no cost. Customers could then dispose of the recalled unused tip holder assemblies. Customers with questions were instruc |
| Quantity | 4,440 units |
| Distribution | Worldwide Distribution - USA including AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MN, MO, MT, NC, NE, NJ, NY, OH, OR, PA, TX, UT, VA, WA, WI, OH and Internationally to Bulgaria, Germany, Italy, Japan, South Korea, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122514 | VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST Nanosphere, Inc., Sep 19, 2012 |