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Opgen Inc recalls AdvanDx QuickFISH Slides, a component of the QuickFish BC Fixation Kit - BC, REF QFFIXBC1-25, Catalog Number: CS012 C
Recalled July 25, 2018 · FDA recall Z-2439-2018 · Opgen
Hazard
Possible diminished performance prior to its established expiration date. · FDA Class II
Units
800 total (32 kits/25 slides per kit)
Sold at
Worldwide Distribution: US (nationwide) to states of: AZ, CA, IL, TX & WA; and countries of: Italy & Denmark.
Description
Possible diminished performance prior to its established expiration date.
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.
Manufacturer(s)
Opgen Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →