Recall Z-2168-2014 ยท OZN C. Difficile Toxin Gene Amplification Assay
Nanosphere, Inc.
Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification o
| Date | Aug 8, 2014 (initiated Oct 16, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | Nanosphere sent an Field Notification Letter dated October 16, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letters included instructions for customers to: 1) discontinue use of the affected product, 2) discard any of the affected product, and 3) complete the attached form and return it to Nanosphere. Customers with questions can contact Nanosphere at 847-400-9000 or 888-837-4436 x 2. |
| Quantity | 280 sets of trays |
| Distribution | US Distribution including the states of CA and WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123197 | VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) Nanosphere, Inc., Dec 5, 2012 |