# FDA recall Z-1691-2020

> **Microbiologics Inc** · Class II · device recall initiated 2020-02-12.

## 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.

## Distribution

Nationwide, Including Australia, Brazil, Curacao, Ecuador, Germany, Greece, Italy, Puerto Rico, Singapore, Turkey, United States, Uruguay and Australia.

## Key facts

- **Recall number:** Z-1691-2020
- **Recalling firm:** Microbiologics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-12
- **Report date:** 2020-04-15
- **Termination date:** 2021-03-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Cloud, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1691-2020

## Citation

> AI Analytics. FDA recall Z-1691-2020. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1691-2020. Source: US FDA. Licensed CC0.

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