FDA recall Z-2439-2018

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.

Reason for recall

Possible diminished performance prior to its established expiration date.

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-05-14

Report date

2018-07-25

Termination date

2019-04-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gaithersburg, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2439-2018