FDA-Device2024-04-17Class II

KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media

Microbiologics Inc
Hazard

The positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminated with another fungal organism (Aspergillus brasiliensis). As a result, users may observe A. brasiliensis growth when using the control material.

Sold states
Worldwide - US Nationwide distribution in the states of CA, MI, KY, MO, NM, TN, PR, and the countries of France, Columbia, Kazakhstan, Peru, Puerto Rico, South Africa.
Affected count
19 units
Manufactured in
200 Cooper Ave N, N/A, Saint Cloud, MN, United States
Products
KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1483-2024

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