Recall Z-2439-2018
Opgen Inc · initiated May 14, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot Number: 17306401 Expiration Date: November 2018 (2018-11)
Reason for recall
Possible diminished performance prior to its established expiration date.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-2439-2018
- Initiated
- May 14, 2018
- Terminated
- April 8, 2019
- Product code
- LJG – Quality Control Slides
- 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.
- Recalling firm
- Opgen Inc, Gaithersburg, MD