Z-2439-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 25, 2018
- Initiation Date
- May 14, 2018
- Termination Date
- April 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 800 total (32 kits/25 slides per kit)
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.
Reason for Recall
Possible diminished performance prior to its established expiration date.
Distribution Pattern
Worldwide Distribution: US (nationwide) to states of: AZ, CA, IL, TX & WA; and countries of: Italy & Denmark.
Code Information
Lot Number: 17306401 Expiration Date: November 2018 (2018-11)