Microbiologics QC SETS AND PANELS — Class II medical device recall Z-1691-2020
Terminated recall by Microbiologics Inc, reported 2020-04-15, distributed nationwide. KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) contain produ
| Recall number | Z-1691-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microbiologics Inc, Saint Cloud, MN, United States |
| Recall initiated | 2020-02-12 |
| Classified | 2020-04-09 |
| Reported by FDA | 2020-04-15 |
| Terminated | 2021-03-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CW, DE, EC, GR, IT, SG, TR, UY |
| Quantity | 49 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 70845357030770 |
| Lot numbers | 5195-04, 5195-05 |
| Model numbers | 5195P |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1691-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.