The Recall Desk

Manufacturer

Opgen Inc

2 recalls in our database name Opgen Inc as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2019-05-22

Of the 2 recalls from Opgen Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • ModerateFDA (Devices)·Z-1328-2019·2019-05-22

    Opgen Recalls GNR PNA FISH Control Slides Due to Performance Issues

    Opgen Inc is recalling 80 GNR PNA FISH Control Slides because they may show diminished performance before expiration, potentially causing invalid test results.

    Product
    CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control Slide kit . In-Vitro Diagnostic The CS011 GNR Traffic Light Control Slide provides a positive and negative control for the KT011 GNR Traffic Light PNA FISH kit. GNR Traffic Lig
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2439-2018·2018-07-25

    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.

    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 samp
    Category
    Medical Device
    Distribution
    Distributed nationwide