Z-1690-2020Class II

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

Name: Z-1690-2020 KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3)
Creator: Microbiologics Inc
Published: 2020-02-12
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2020-02-12 / Terminated / root cause: manufacturing process

FDA source

Microbiologics Inc began a recall of KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3) on 2020-02-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1690-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-12
Posted: 2020-04-09
Terminated: 2021-03-26
Recalling firm: Microbiologics, Inc.
Product: KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3)
Product code: JTR Kit, Quality Control For Culture Media
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Microbiologics notified customer on 02/12/2020 via "Urgent Medical Device Correction" letter. The recall letter was emailed to consignees and the consignees were instructed to properly discard any affected products they have. The recall letter identified the affected product and lot numbers. Reason for the correction was also noted in the recall letter.
Quantity in commerce: 49 units
Distribution: Nationwide, Including Australia, Brazil, Curacao, Ecuador, Germany, Greece, Italy, Puerto Rico, Singapore, Turkey, United States, Uruguay and Australia.
Product codes and lots: Catalog Number: 0778P. Lot Number: 778-65-3. UDI 20845357018773.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1690-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1690-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-09
Z-1691-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-09

Product code JTR

K861022Class IKwik Stik(tm) Lyfo(tm) Disk MicroorganismsMicro-Bio-Logics / cleared 1986-04-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)