FDA Enforcement
Class III
Terminated
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.
Recall: Z-0636-2022
·
Reported February 16, 2022
Enforcement
- Recall Number
- Z-0636-2022
- Event ID
- 89412
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Microbiologics Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 16, 2022
- Initiation Date
- March 2, 2017
- Classification Date
- February 10, 2022
- Termination Date
- April 22, 2022
- Address
- 200 Cooper Ave N, N/A, Saint Cloud, MN, 56303-4440, United States
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
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
Code Info
Catalog Number: 0939P, Lot Number: 939-47-2, UDI: 20845357022701
Distribution
International distribution in the countries of Canada and Germany.
Quantity
2 units