Recall Z-2681-2014
Nanosphere, Inc. · initiated October 10, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
The 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.
Codes / lots: Product Number: 20-009-021; Lot Number and Expiration Date: Lot: 100113021C, Expiration Date: 03/30/14
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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 instructed to contact their Nanosphere technical support representative. For questions regarding this recall call 1-888-837-4436, ext 3.
Details
- Recall number
- Z-2681-2014
- Initiated
- October 10, 2013
- Posted by FDA
- September 23, 2014
- Terminated
- June 16, 2015
- Product code
- PEN – Gram-Negative Bacteria And Associated Resistance Markers
- Quantity
- 400 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.
- Recalling firm
- Nanosphere, Inc., Northbrook, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2682-2014 Class II | The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed…Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures… | 10/10/2013Terminated |
| Z-2683-2014 Class II | The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the…Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures… | 10/10/2013Terminated |
| Z-2684-2014 Class II | The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a…Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures… | 10/10/2013Terminated |
| Z-2685-2014 Class II | The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test…Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures… | 10/10/2013Terminated |