Reported Jul 25, 2018 · Terminated

AdvanDx QuickFISH Slides, a component of the QuickFish BC Fixation Kit - BC, REF QFFIXBC1-25, Catalog Number: CS012…

Opgen Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Opgen Inc · 708 Quince Orchard Rd Ste 220 · Gaithersburg, MD · 20878-1764

Is this the product you have?

  • AdvanDx QuickFISH Slides, a component of the QuickFish BC Fixation Kit - BC, REF QFFIXBC1-25
  • Catalog NumberCS012 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
Lot codes and dates
  • Lot Number17306401
  • Expiration DateNovember 2018 (2018-11)
Amount recalled
800 total (32 kits/25 slides per kit)

Where it was sold

Why it was recalled

Possible diminished performance prior to its established expiration date.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 8, 2019 · Data as of Sep 19, 6:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.