FDA Medical Device Recalls (openFDA)
AdvanDx, Inc.: 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
- Recall number
- Z-0619-2014
- Recalling firm
- AdvanDx, Inc.
- 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
- Status
- Terminated
- Initiated
- 2013-12-11
- Posted
- 2014-01-02
- Terminated
- 2014-01-13
- Reason
- Kits incompatible with certain fluorescence microscope light sources
- Root cause
- Process design
- Action
- AdvanDx issued an email notification along with a PDF file of the new package insert to each customer followed by written notification dated December 6, 2013 and a paper copy of the new package insert via Fed Ex courier. All customers received an acknowledgement form to fill out and return to AdvanDx so that the effectiveness of the replacement can be evaluated. All existing inventory of Gram-Negative QuickFISH BC will be repackaged with the new package inert Customers with questions were instructed to contact AdvanDx Technical Support at 1-866-376-0009 or techwupport@advandx.com. For questions regarding this recall call 781-376-0009.
- Quantity
- 49 kits US; 17 kits OUS
- Distribution
- Worldwide Distribution - USA including CA, IL, IN, OH, NJ, MI , MO, NY, WI. Internationally to Denmark.
- Lot, serial or model codes
- Lot codes US: 04813C, 7413, 08113 exp. 2013-12 Lot codes OUS: 03113A 04213A 04813B
- 510(k) numbers
- ["K123418"]
- PMA numbers
- not on file
- Product code
- JSS
- Firm FEI
- 3004080598
- Firm city
- Woburn
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28