Skip to content
Recall Observatory FDA recall evidence

Device product

KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3)

Z-1690-2020

February 12, 2020

Class II

Product summary

Firm
Microbiologics Inc
Event
Event 85009
Status
Terminated
Classification
Class II
Quantity
49 units
Official record key
device-enforcement:Z-1690-2020

Official wording

Reason: KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) contain product labeled as Trichosporon dermatis (T. dermatis) which may contain Candida Utilis instead of T. dermatis.

Code information: Catalog Number: 0778P. Lot Number: 778-65-3. UDI 20845357018773.

Distribution pattern: Nationwide, Including Australia, Brazil, Curacao, Ecuador, Germany, Greece, Italy, Puerto Rico, Singapore, Turkey, United States, Uruguay and Australia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) contain product labeled as Trichosporon dermatis (T. dermatis) which may contain Candida Utilis instead of T. dermatis.