AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are
FDA device recall Z-2138-2014 · posted 2014-08-01 · Terminated
Recall details
- Recalling firm
- Advandx Inc
- Reason for recall
- Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC
- Action taken
- AdvanDx notified customers by e-mail on July 4, 2014 of the problem and advised to discontinue use of the QuickFISH Fixation Kits with Lot#04914. Replacement kits were immediately shipped to all of the affected customers. Questions contact local AdvanDx representative or Technical Support 1-866-376-0009, fax 1-781-376-0111 or e-mail: techsupport@advandx.com. An acknowledgement of Receipt and Destruction of Materials requested to be completed.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- NXX
- Quantity affected
- 10 kits
- Distribution
- Distributed in the states of AZ, ID, FL, MO, OH, MI, NJ, and VA.
- Date initiated
- 2014-07-04
- Date posted
- 2014-08-01
- Date terminated
- 2014-09-30
- Location
- Woburn, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STAPHYLOCOCCUS QUICKFISH BC (K113371) | Advandx, Inc. | 2012-04-03 |