FDA Device recall Z-0619-2014
AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negati…
- FDA Device
- Class III
- terminated
- Published 2014-01-08
On 2014-01-08 the FDA classified a Class III recall of AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negati… by Advandx, citing kits incompatible with certain fluorescence microscope light sources.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0619-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-12-11 |
| Published | 2014-01-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Advandx |
| Distribution | CA, IL, IN, MI, MO, NJ, NY, OH, WI |
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
Identifiers
| code_info | Lot codes US: 04813C, 7413, 08113 exp. 2013-12 Lot codes OUS: 03113A 04213A 04813B |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0619-2014%22
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