FDA recall Z-0637-2022

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.

Reason for recall

Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.

Distribution

International distribution in the countries of Canada and Germany.

Key facts

Status

Terminated

Initiation date

2017-03-02

Report date

2022-02-16

Termination date

2022-04-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Cloud, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0637-2022