Z-1691-2020 Class II Terminated
FDA device recall Z-1691-2020 was initiated by Microbiologics Inc on February 12, 2020 and is designated Class II. 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… The recall status is terminated (terminated March 26, 2021). Affected quantity: 49 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 15, 2020
- Initiation Date
- February 12, 2020
- Termination Date
- March 26, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49 units
Product Description
Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, containing Trichosporon dermatis, ATCC 204094, QR Code: (01)70845357030770, (17)200831, (10)5195-04.
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 Pattern
Nationwide, Including Australia, Brazil, Curacao, Ecuador, Germany, Greece, Italy, Puerto Rico, Singapore, Turkey, United States, Uruguay and Australia.
Code Information
Catalog Number: 5195P (KWIK-STIK kit that contains 0778P). Lot Numbers: 5195-04, 5195-05. UDI 70845357030770.