KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3)
- Company
- Microbiologics Inc
- Recall Initiated
- February 12, 2020
- Terminated
- March 26, 2021
- Recall Number
- Z-1690-2020
- Quantity
- 49 units
- Firm Location
- Saint Cloud, MN
Reason for Recall
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.
Distribution
Nationwide, Including Australia, Brazil, Curacao, Ecuador, Germany, Greece, Italy, Puerto Rico, Singapore, Turkey, United States, Uruguay and Australia.
Lot / Code Info
Catalog Number: 0778P. Lot Number: 778-65-3. UDI 20845357018773.
Root Cause
Nonconforming Material/Component
Action Taken
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.