Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reag
FDA device recall Z-2168-2014 · posted 2014-08-08 · Terminated
Recall details
- Recalling firm
- Nanosphere, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- OZN
- Quantity affected
- 280 sets of trays
- Distribution
- US Distribution including the states of CA and WA
- Date initiated
- 2013-10-16
- Date posted
- 2014-08-08
- Date terminated
- 2015-05-22
- Location
- Northbrook, IL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) (K123197) | Nanosphere, Inc. | 2012-12-05 |