Device 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.
Z-2439-2018
Product summary
- Firm
- Opgen Inc
- Event
- Event 80301
- Status
- Terminated
- Classification
- Class II
- Quantity
- 800 total (32 kits/25 slides per kit)
- Official record key
device-enforcement:Z-2439-2018
Official wording
Reason: Possible diminished performance prior to its established expiration date.
Code information: Lot Number: 17306401 Expiration Date: November 2018 (2018-11)
Distribution pattern: Worldwide Distribution: US (nationwide) to states of: AZ, CA, IL, TX & WA; and countries of: Italy & Denmark.
Derived failure modes
-
Unknown
Possible diminished performance prior to its established expiration date.