FDAClass IIApril 15, 2020

Microbiologics QC SETS AND PANELS recall

Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, containing Trichosporon dermatis, ATCC 204094, QR Code: (01)70845357030770…

Why was Microbiologics QC SETS AND PANELS recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog Number: 5195P (KWIK-STIK kit that contains 0778P). Lot Numbers: 5195-04, 5195-05. UDI 70845357030770.

Product
Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, containing Trichosporon dermatis, ATCC 204094, QR Code: (01)70845357030770…
Recalling firm
Microbiologics Inc
Quantity
49 units
Distribution
Nationwide, Including Australia, Brazil, Curacao, Ecuador, Germany, Greece, Italy, Puerto Rico, Singapore, Turkey, United States, Uruguay and Australia.
Recall date
April 15, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls