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U.S. Department of Health and Human Services

Class 2 Device Recall GNR PNA FISH Control Slide kit CS01110

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  Class 2 Device Recall GNR PNA FISH Control Slide kit CS01110 see related information
Date Initiated by Firm March 18, 2019
Create Date May 14, 2019
Recall Status1 Terminated 3 on August 05, 2019
Recall Number Z-1328-2019
Recall Event ID 82665
Product Classification Quality control slides - Product Code LJG
Product 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
Code Information Lot Number FN80107
Recalling Firm/
Manufacturer		 Opgen Inc
708 Quince Orchard Rd Ste 220
Gaithersburg MD 20878-1764
For Additional Information Contact Michael Farmer
301-869-9683
Manufacturer Reason
for Recall		 May show diminished performance prior to its established expiration date resulting in an invalid control result for the KTOll GNR PNA FISH Test
FDA Determined
Cause 2		 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 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
Quantity in Commerce 80 slides
Distribution US Distribution to states of: CT, MI and VA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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