AdvanDx QuickFISH Slides — Class II medical device recall Z-2439-2018
Terminated recall by Opgen Inc, reported 2018-07-25, distributed nationwide. Possible diminished performance prior to its established expiration date.
| Recall number | Z-2439-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Opgen Inc, Gaithersburg, MD, United States |
| Recall initiated | 2018-05-14 |
| Classified | 2018-07-13 |
| Reported by FDA | 2018-07-25 |
| Terminated | 2019-04-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | DK, IT |
| Lot numbers | 17306401 |
| Model numbers | CS012, QFFIXBC1-25 |
| Expiration dates | 2018-11-20 |
Product
AdvanDx QuickFISH Slides, a component of the QuickFish BC Fixation Kit - BC, REF QFFIXBC1-25, Catalog Number: CS012 Control slides included as a component of the QFFIXBC1-25. The slides will provide non-fluorescent, wettable surface with dimensions appropriate for testing samples with QuickFISH BC culture identification kits.
Reason for recall
Possible diminished performance prior to its established expiration date.
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-2439-2018. 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.