Recall Z-1328-2019 ยท LJG Quality Control Slides
Opgen Inc
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 cu
| Date | Mar 18, 2019 |
| Status | Terminated |
| Reason | May show diminished performance prior to its established expiration date resulting in an invalid control result for the KTOll GNR PNA FISH Test |
| Root cause | Under Investigation by firm |
| Action | 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 reque |
| Quantity | 80 slides |
| Distribution | US Distribution to states of: CT, MI and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.