Recall Z-2439-2018 ยท LJG Quality Control Slides
Opgen Inc
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.
| Date | May 14, 2018 |
| Status | Terminated |
| Reason | Possible diminished performance prior to its established expiration date. |
| Root cause | Under Investigation by firm |
| Action | On May 9, 2018, OpGen, Inc. notified all affected customers by email. On May 14, 2018, OpGen, Inc. (formerly AdvanDx, Inc.) issued Medical Device Recall notices and acknowledgement forms to their customers via email. Customers were advised to take the following actions: - Inspect stock, quarantine the impacted product and dispose of it in the proper manner. - Complete and return the Acknowledgement of Receipt and Destruction of Materials Form via mail to: OpGen, Inc. Attn: Regulatory Affairs, 708 Quince Orchard Dr., Suite 205, Gaithersburg MD 20878; Fax to: 1 (30) 869-9684 or email to: reg |
| Quantity | 800 total (32 kits/25 slides per kit) |
| Distribution | Worldwide Distribution: US (nationwide) to states of: AZ, CA, IL, TX & WA; and countries of: Italy & Denmark. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.