Recall Z-0636-2022— 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: KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. A KWIK-STIK" catalog number ending in P is a duopak and contains two KWIKSTIK" sticks.. 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
KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. A KWIK-STIK" catalog number ending in P is a duopak and contains two KWIKSTIK" sticks.
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.