The Verigene Enteric Pathogens Nucleic Acid Test recall
The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common…
Why was The Verigene Enteric Pathogens Nucleic Acid Test recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Number: (Not Applicable); Lot Numbers and Expiration Dates: 1) Lot: 091313023CIUO, Expiration Date: 03/12/14; 2) Lot 092713023CIUO, Expiration Date: 03/26/14
- Product
- The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common…
- Recalling firm
- Nanosphere, Inc.
- Quantity
- 220 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.
- Recall date
- October 1, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)