FDAClass IIJuly 25, 2018

AdvanDx QuickFISH Slides recall

AdvanDx QuickFISH Slides, a component of the QuickFish BC Fixation Kit - BC, REF QFFIXBC1-25, Catalog Number: CS012 Control slides included as a…

Why was AdvanDx QuickFISH Slides recalled?

Possible diminished performance prior to its established expiration date.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: 17306401 Expiration Date: November 2018 (2018-11)

Product
AdvanDx QuickFISH Slides, a component of the QuickFish BC Fixation Kit - BC, REF QFFIXBC1-25, Catalog Number: CS012 Control slides included as a…
Recalling firm
Opgen Inc
Quantity
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.
Recall date
July 25, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls