FDA-Device2022-01-26Class II

KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 36299.

Microbiologics Inc
Hazard

Contamination with S. epidermidis

Sold states
Distribution was made to CA, IA, IL, LA, MA, MI, NY, PA, SD, TN, VA, WI, and WV. There was no government/military distribution. Foreign distribution was made to Brazil, Canada, Colombia, Dominican Republic, Finland, France, India, Japan, Malaysia, Mexico, Netherlands, Poland, Romania, Saudi Arabia, Serbia, South Africa, and United Kingdom.
Affected count
59 kits
Manufactured in
200 Cooper Ave N, N/A, Saint Cloud, MN, United States
Products
KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 36299.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0511-2022

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