Opgen Inc Recalls
Showing 1-2 of 2 recalls
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 for the KT011 GNR Traffic Light PNA FISH kit. GNR Traffic Light PNA FISH provides rapid identification of E. coli, K. pneumoniae and P. aeruginosa directly from Gram-negative blood cultures
May show diminished performance prior to its established expiration date resulting in an invalid control result for the KTOll GNR PNA FISH Test
OpGen issued recall letter via email on March 18, 2019. The notification provided reason for recall, health risk, and request to destroy any remaining inventory and return the completed Acknowledgement of Receipt of Notification Letter via OpGen, Inc., Attn: Autumn Collasius Regulatory Affairs,708 Quince Orchard Dr., Suite 205, Gaithersburg, MD 20878; Phone: 1 (301) 869-9683 Fax: 1 (301) 869-9684, e-mail: regulatory@opgen.com. The response form asks the customer to include how many of the affected slides they currently have in stock and how many they have already used. Questions or requests for further information, please contact OpGen Technical Support: US (Toll-Free): 1-866-376-0009 FAX: 1-301-869-9684 E-mail: techsupport@opgen.com
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.
Possible diminished performance prior to its established expiration date.
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.