AdvanDx Gram-Negative QuickFISH BC — Class III medical device recall Z-0619-2014
Terminated recall by AdvanDx, Inc., reported 2014-01-08, distributed in CA, IL, IN, MI, MO, NJ, NY, OH…. Kits incompatible with certain fluorescence microscope light sources
| Recall number | Z-0619-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AdvanDx, Inc., Woburn, MA, United States |
| Recall initiated | 2013-12-11 |
| Classified | 2014-01-02 |
| Reported by FDA | 2014-01-08 |
| Terminated | 2014-01-13 |
| Distributed | CA, IL, IN, MI, MO, NJ, NY, OH, WI |
| Countries outside the US | DK |
| Lot numbers | 03113A, 04213A, 04813B, 04813C, 08113, 2013-12, 7413 |
| Model numbers | QFGNRBC1-25 |
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 for recall
Kits incompatible with certain fluorescence microscope light sources
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0619-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.