Class III — Microbiologics Inc
| Recalling firm | Microbiologics, Inc. |
|---|---|
| Registered facility | Microbiologics, Inc. (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. |
| 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. |
| Quantity | 2 units |
| Distribution | International distribution in the countries of Canada and Germany. |
| Initiated | 2017-03-02 |
| Classified | 2022-02-10 |
| Terminated | 2022-04-22 |
| Recall number | Z-0636-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Microbiologics Inc (Z-0636-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89412/
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