Recall Z-2439-2018— Opgen Inc
Class II · Terminated
Class II FDA medical device recall by Opgen Inc, initiated 2018-05-14, terminated 2019-04-08. FDA's recall record names no specific 510(k) clearance for this event. 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: Possible diminished performance prior to its established expiration date..
- Recalling firm
- Opgen Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-05-14
- Terminated
- 2019-04-08
- Firm location
- Gaithersburg, MD, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.