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Terminated

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

FDA Recall Z-1690-2020 · Posted None

Recalling FirmMicrobiologics Inc
Recall StatusTerminated
Product CodeJTR
Date Initiated2020-02-12
Date Terminated2021-03-26
Product Quantity49 units

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K861022KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMSMicro-Bio-Logics · 1986-04-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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