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FDA (Device enforcement)Recalled 2020-02-12closedclass ii

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

Is my product affected?

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

  • UPC 20845357018773

Check against the official notice below — it lists the full affected range.

What happened

Microbiologics Inc. is recalling KWIK-STIK 2 Pack Trichosporon dermatis (Catalog# 0778P, Lot 778-65-3) and KWIKSTIK YST Comprehensive QC Set (Catalog# 5195P) because products labeled as Trichosporon dermatis may contain Candida Utilis instead. A total of 49 units have been distributed nationwide and internationally to Australia, Brazil, Curacao, Ecuador, Germany, Greece, Italy, Puerto Rico, Singapore, Turkey, Uruguay, and the United States.

The recall record does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. Quantity: 49 units Lot/code info: Catalog Number: 0778P. Lot Number: 778-65-3. UDI 20845357018773.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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