Microbiologics Inc: 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.

Is my product affected?

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.

• UPC 70845357030770

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

What happened

Microbiologics Inc. is recalling its KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels KWIKSTIK YST Comprehensive QC Set (REF 5195P) distributed nationwide and internationally to countries including Australia, Brazil, Germany, Italy, Singapore, Turkey, and the United States. The products are labeled as containing Trichosporon dermatis but may instead contain Candida Utilis. A total of 49 units have been affected, with lot numbers 5195-04 and 5195-05.

The recall affects microbiological quality control products used in laboratory testing. Affected products can be identified by catalog number 5195P, lot numbers 5195-04 or 5195-05, and UDI code 70845357030770. The source document 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: 5195P (KWIK-STIK kit that contains 0778P). Lot Numbers: 5195-04, 5195-05. UDI 70845357030770.

Source

Official record: FDA (Device enforcement) ↗

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

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