FDA-Device2022-02-16Class III
LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single microorganism strain, in a glass vial. Each vial is sealed and contains a desiccant to prevent adverse moisture accumulation. A LYFO Disk" catalog number ends in L.
Microbiologics Inc
Hazard
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
Sold states
International distribution in the countries of Canada and Germany.
Affected count
1 unit
Manufactured in
200 Cooper Ave N, N/A, Saint Cloud, MN, United States
Products
LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single microorganism strain, in a glass vial. Each vial is sealed and contains a desiccant to prevent adverse moisture accumulation. A LYFO Disk" catalog number ends in L.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0637-2022Don't want to check this manually?
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