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Class 2 Device Recall AdvanDx QuickFISH Slides |
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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
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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
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Manufacturer Reason for Recall |
Possible diminished performance prior to its established expiration date.
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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
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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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