Recall Z-0637-2022— Microbiologics Inc
Class III · Terminated
Class III FDA medical device recall by Microbiologics Inc, initiated 2017-03-02, terminated 2022-04-22. It names one FDA 510(k) clearance: K861022. 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: Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta..
- Recalling firm
- Microbiologics Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2017-03-02
- Terminated
- 2022-04-22
- Firm location
- Saint Cloud, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.