Opgen Inc: Medical Device Recall in 2018 - (Recall #: Z-2439-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: May 14, 2018

Date Posted: July 25, 2018

Recall Number: Z-2439-2018

Event ID: 80301

Reason for Recall:

Possible diminished performance prior to its established expiration date.

Status: Terminated

Product Quantity: 800 total (32 kits/25 slides per kit)

Code Information:

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

Distribution Pattern:

Worldwide Distribution: US (nationwide) to states of: AZ, CA, IL, TX & WA; and countries of: Italy & Denmark.

Voluntary or Mandated:

Voluntary: Firm initiated