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ModerateClass IITerminated

FDA Devices recall · Reported April 15, 2020

KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3)

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 C…

Recall #
Z-1690-2020
Affected scope
49 units
Initiated
February 12, 2020
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The recall

Microbiologics Inc issued this moderate-severity FDA Devices recall — KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) contain prod….

Moderate
severity level
49 units
affected scope
Class II
classification
April 15, 2020
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1690-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1690-2020) was formally reported on April 15, 2020, with the manufacturer initiating the action on February 12, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Microbiologics Inc is listed as the recalling firm, operating out of Saint Cloud, MN. Federal records list the affected scope as 49 units.

The documented reason for this recall is: 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 data in the federal record shows the product reached: Nationwide, Including Australia, Brazil, Curacao, Ecuador, Germany, Greece, Italy, Puerto Rico, Singapore, Turkey, United States, Uruguay and Australia.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category — 40,409 medical devices recalls on record

-1,00001,0002,0003,0004,0005,000 20052008201120142017202020232026 1,243

Where this recall sits in the database

Severity2366872097High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.

Severity

Moderate

Affected scope

49 units

Related Recalls

6

6 from same agency

Product description

KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3)

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-1690-2020
Date reported April 15, 2020
Date initiated February 12, 2020
Recalling firm Microbiologics Inc
Firm location Saint Cloud, MN
Affected scope 49 units
Distribution Nationwide, Including Australia, Brazil, Curacao, Ecuador, Germany, Greece, Italy, Puerto Rico, Singapore, Turkey, United States, Uruguay and Australia.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

49 units units affected — limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units)
Large-scale (100K – 1M units)
Massive (≥1M units)

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-1690-2020) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting — recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3). Recalled by Microbiologics Inc. Units affected: 49 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 15, 2020. Severity: Moderate. Recall number: Z-1690-2020.
Where was the recalled product distributed?
Distribution: Nationwide, Including Australia, Brazil, Curacao, Ecuador, Germany, Greece, Italy, Puerto Rico, Singapore, Turkey, United States, Uruguay and Australia..
How do I check if my product is affected by a recall?
Check the product description and recall number (Z-1690-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

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Data Sources

Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported April 15, 2020.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.