FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2439-2018
- Recalling firm
- Opgen Inc
- 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 samples with QuickFISH BC culture identification kits.
- Status
- Terminated
- Initiated
- 2018-05-14
- Posted
- not on file
- Terminated
- 2019-04-08
- 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: regulatory@opgen.com. - 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 techsupport@opgen.com. Customers with questions may contact the firm via telephone 1-866-376-0009 or by e-mail: techsupport@opgen.com.
- 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.
- Lot, serial or model codes
- Lot Number: 17306401 Expiration Date: November 2018 (2018-11)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LJG
- Firm FEI
- 3007065145
- Firm city
- Gaithersburg
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28