KWIK-STIK Trichosporon Dermatis (Microbiologics) – labeling error (2020)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3)
Brand
Microbiologics Inc
Lot Codes / Batch Numbers
Catalog Number: 0778P. Lot Number: 778-65-3. UDI 20845357018773.
Products Sold
Catalog Number: 0778P. Lot Number: 778-65-3. UDI 20845357018773.
Microbiologics Inc is recalling KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3) due to KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) contain product labeled as Trichosporon dermatis (T. . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Microbiologics notified customer on 02/12/2020 via "Urgent Medical Device Correction" letter. The recall letter was emailed to consignees and the consignees were instructed to properly discard any affected products they have. The recall letter identified the affected product and lot numbers. Reason for the correction was also noted in the recall letter.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026