The Verigene Gram-Positive Blood Culture Nucleic Acid recall
The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sample-to-result Verigene System is a qualitative, multiplexed…
Why was The Verigene Gram-Positive Blood Culture Nucleic Acid 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: 20-009-018; Lot Numbers and Expiration Dates: 1) Lot: 090613018B, Expiration Date: 03/05/14; 2) Lot: 091413018B, Expiration Date: 03/13/14; 3) Lot: 091713018C, Expiration Date: 03/16/14; 4) Lot: 091813018B, Expiration Date: 03/17/14; 5) Lot: 092113018C, Expiration Date: 03/20/14; 6) Lot: 100213018B, Expiration Date: 03/31/14
- Product
- The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sample-to-result Verigene System is a qualitative, multiplexed…
- Recalling firm
- Nanosphere, Inc.
- 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.
- Recall date
- October 1, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)