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U.S. Department of Health and Human Services

Class 2 Device Recall AdvanDx QuickFISH Slides

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  Class 2 Device Recall AdvanDx QuickFISH Slides see related information
Date Initiated by Firm May 14, 2018
Create Date July 13, 2018
Recall Status1 Terminated 3 on April 08, 2019
Recall Number Z-2439-2018
Recall Event ID 80301
Product Classification Quality control slides - Product Code LJG
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.
Code Information Lot Number: 17306401 Expiration Date: November 2018 (2018-11)
Recalling Firm/
Manufacturer		 Opgen Inc
708 Quince Orchard Rd Ste 220
Gaithersburg MD 20878-1764
Manufacturer Reason
for Recall		 Possible diminished performance prior to its established expiration date.
FDA Determined
Cause 2		 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 in Commerce 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.
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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