AdvanDx Quick FISH Fixation Kit for BC — Class II medical device recall Z-2138-2014
Terminated recall by Advandx Inc, reported 2014-08-13, distributed in AZ, FL, ID, MI, MO, NJ, OH, VA. Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC
| Recall number | Z-2138-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advandx Inc, Woburn, MA, United States |
| Recall initiated | 2014-07-04 |
| Classified | 2014-08-01 |
| Reported by FDA | 2014-08-13 |
| Terminated | 2014-09-30 |
| Distributed | AZ, FL, ID, MI, MO, NJ, OH, VA |
| Quantity | 10 kits |
| Pathogens | staphylococcus |
| Lot numbers | 04914, 2015-06 |
| Model numbers | QFFIXBC1-50 |
Product
AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test Catalog number: QFFixBC1-50 (a component for QFSTABC1-50)
Reason for recall
Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC
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-2138-2014. 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.