Nanosphere Verigene Each CDF test consists of a recall
Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. The Verigene…
Why was Nanosphere Verigene Each CDF test consists of a recalled?
Nanosphere has received report of an increased rate of "No Call - INT CTL 2" results for the Internal Control 2 (INT CTL 2) when negative samples are tested with certain lots of CDF Amplification Trays (20-011-022), which are contained in the CDF Amplification Reagent Kit (20-012-022); specifically for lots 061913022D and 071813022E.
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?
Verigene CDF Amplification Trays, Catalog Number: 20-011-022, Lot Numbers: 061913022D and 071813022E
- Product
- Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. The Verigene…
- Recalling firm
- Nanosphere, Inc.
- Quantity
- 280 sets of trays
- Distribution
- US Distribution including the states of CA and WA
- Recall date
- August 20, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)