Gaithersburg, MD, United States
Opgen Inc recalls
2 recalls recorded since 2018, most recently on 18 March 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 18 March 2019
- Terminated
- 5 August 2019
- Reason
- May show diminished performance prior to its established expiration date resulting in an invalid control result for the KTOll GNR PNA FISH Test
- Distribution
- US Distribution to states of: CT, MI and VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1328-2019
- 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 f
Terminated Class II Medical devices
- Recall started
- 14 May 2018
- Terminated
- 8 April 2019
- Reason
- Possible diminished performance prior to its established expiration date.
- Distribution
- Worldwide Distribution: US (nationwide) to states of: AZ, CA, IL, TX & WA; and countries of: Italy & Denmark.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2439-2018
- 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, w
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.