Z-2439-2018Class II

AdvanDx QuickFISH Slides, a component of the QuickFish BC Fixation Kit - BC, REF QFFIXBC1-25, Catalog Number...

Name: Z-2439-2018 AdvanDx QuickFISH Slides, a component of the QuickFish BC Fixation Kit - BC, REF QFFIXBC1-25, Catalog Number...
Creator: Opgen Inc
Published: 2018-05-14
License: https://open.fda.gov/license/

Opgen Inc / initiated 2018-05-14 / Terminated

FDA source

Opgen Inc began a recall of 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... on 2018-05-14. FDA classified it as Class II and gives the reason as "Possible diminished performance prior to its established expiration date". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2439-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-14
Posted: 2018-07-13
Terminated: 2019-04-08
Recalling firm: Opgen Inc
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.
Product code: LJG Quality Control Slides
Reason for recall: Possible diminished performance prior to its established expiration date.
FDA root cause: 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: [email protected]. - 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 [email protected]. Customers with questions may contact the firm via telephone 1-866-376-0009 or by e-mail: [email protected].
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.
Product codes and lots: Lot Number: 17306401 Expiration Date: November 2018 (2018-11)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2439-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2439-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-13

Product code LJG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)