Z-0637-2022 Class III Terminated
FDA device recall Z-0637-2022 was initiated by Microbiologics Inc on March 2, 2017 and is designated Class III. Reason for recall: Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. The recall status is terminated (terminated April 22, 2022). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- February 16, 2022
- Initiation Date
- March 2, 2017
- Termination Date
- April 22, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
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 Pattern
International distribution in the countries of Canada and Germany.
Code Information
Catalog Number: 0939L, Lot Number: 939-47-1, UDI: 10845357022728