Device 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.
Z-0636-2022
Product summary
- Event
- Event 89412
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2 units
- Official record key
device-enforcement:Z-0636-2022
Official wording
Reason: Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
Code information: Catalog Number: 0939P, Lot Number: 939-47-2, UDI: 20845357022701
Distribution pattern: International distribution in the countries of Canada and Germany.
Derived failure modes
-
Unknown
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.