Recall Z-0619-2014— AdvanDx, Inc.
Class III · Terminated
Class III FDA medical device recall by AdvanDx, Inc., initiated 2013-12-11, terminated 2014-01-13. It names one FDA 510(k) clearance: K123418. Product: AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negative QuickFISH BC provides rapid identification of Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae directly from GNR-positive blood cultures. Reason: Kits incompatible with certain fluorescence microscope light sources.
- Recalling firm
- AdvanDx, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2013-12-11
- Terminated
- 2014-01-13
- Firm location
- Woburn, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negative QuickFISH BC provides rapid identification of Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae directly from GNR-positive blood cultures
Reason for recall
Kits incompatible with certain fluorescence microscope light sources
Data sourced from openFDA. This site is unofficial and independent of the FDA.