Device 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.
Z-0637-2022
Product summary
- Event
- Event 89412
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-0637-2022
Official wording
Reason: Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
Code information: Catalog Number: 0939L, Lot Number: 939-47-1, UDI: 10845357022728
Distribution pattern: International distribution in the countries of Canada and Germany.
Derived failure modes
-
Unknown
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.