Home / Recalls / Medical Devices
Microbiologics Inc recalls LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellet
Recalled February 16, 2022 · FDA recall Z-0637-2022 · Microbiologics
Hazard
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. · FDA Class III
Units
1 unit
Sold at
International distribution in the countries of Canada and Germany.
Description
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
Product
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.
Manufacturer(s)
Microbiologics Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →