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.
FDA Recall Z-2439-2018 · Posted None
Recalling FirmOpgen Inc
Recall StatusTerminated
Product CodeLJG
Date Initiated2018-05-14
Date Terminated2019-04-08
Product Quantity800 total (32 kits/25 slides per kit)
Reason for Recall
Possible diminished performance prior to its established expiration date.
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: [email protected].
- Should you encounter any false positive or false negative results in
either control well of QuickFISH Slides Lot 17306401, please contact OpGen Technical Support immediately at [email protected].
Customers with questions may contact the firm via telephone 1-866-376-0009 or by e-mail: [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide Distribution: US (nationwide) to states of: AZ, CA, IL, TX & WA; and countries of: Italy & Denmark.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.