Opgen Recalls AdvanDx QuickFISH Slides Due to Diminished Performance
Opgen Inc is recalling AdvanDx QuickFISH Slides because they may show diminished performance before their expiration date.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a performance issue without reporting specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Opgen Inc is recalling AdvanDx QuickFISH Slides, which are a component of the QuickFish BC Fixation Kit - BC (REF QFFIXBC1-25, Catalog Number: CS012). The recall involves 800 total slides (32 kits with 25 slides per kit) with Lot Number 17306401 and an expiration date of November 2018.
The recall was initiated because the slides may exhibit possible diminished performance prior to their established expiration date. These control slides are intended to provide a non-fluorescent, wettable surface for testing samples with QuickFISH BC culture identification kits.
The affected products were distributed worldwide, including nationwide in the United States to the states of Arizona, California, Illinois, Texas, and Washington, as well as to Italy and Denmark. Users should stop using the affected slides and contact Opgen Inc for further instructions.
The recalled product
- 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…
- Manufacturer
- Opgen Inc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 17306401 Expiration Date: November 2018 (2018-11)
Distribution
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