FDA Device recall Z-0636-2022
KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus
- FDA Device
- Class III
- terminated
- Published 2022-02-16
On 2022-02-16 the FDA classified a Class III recall of KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus by Microbiologics, citing potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0636-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-03-02 |
| Published | 2022-02-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Microbiologics |
| Distribution | n/a |
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.
Identifiers
| code_info | Catalog Number: 0939P, Lot Number: 939-47-2, UDI: 20845357022701 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Other recalls by Microbiologics
- KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
FDA Device · Class II · 2025-12-31 · Microbiologics - LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
FDA Device · Class II · 2025-12-31 · Microbiologics - KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
FDA Device · Class II · 2025-12-31 · Microbiologics - KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
FDA Device · Class II · 2025-12-10 · Microbiologics - LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
FDA Device · Class II · 2025-08-06 · Microbiologics
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0636-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.