Microbiologics QC Sets Recalled for Potential Mislabeling of Fungal Strains
Microbiologics Inc is recalling QC sets that may contain Candida utilis instead of the labeled Trichosporon dermatis.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a labeling error regarding the specific fungal strain in a quality control product, which fits the criteria for moderate severity involving minor labeling errors or low-risk contamination without reported injuries.
Plain-English summary
Microbiologics Inc is recalling KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels, specifically the KWIKSTIK YST Comprehensive QC Set (REF 5195P). The recall involves 49 units distributed nationwide and internationally, including in Australia, Brazil, Curacao, Ecuador, Germany, Greece, Italy, Puerto Rico, Singapore, Turkey, the United States, and Uruguay.
The reason for the recall is that the product is labeled as containing Trichosporon dermatis (T. dermatis), but it may contain Candida utilis instead. This misidentification could affect the accuracy of quality control testing performed using these sets.
Users of these products should stop using the affected lots (5195-04 and 5195-05) and contact Microbiologics Inc for further instructions or a replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Microbiologics Inc
- Hazard
- Affected units
- 49
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Catalog Number: 5195P (KWIK-STIK kit that contains 0778P). Lot Numbers: 5195-04
- 5195-05. UDI 70845357030770.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Microbiologics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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