Class II — Microbiologics Inc
| Recalling firm | Microbiologics, Inc. |
|---|---|
| Registered facility | Microbiologics, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | KWIK-STIK 6 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145K) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative. |
| Product | Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2 or 6. |
| Quantity | 1 unit |
| Distribution | Distribution in US, Brazil, Canada, Costa Rica, France, Germany, Ireland, Italy, Japan, New Zealand, Sweden, and United Kingdom. |
| Initiated | 2020-10-08 |
| Classified | 2020-10-27 |
| Terminated | 2022-11-17 |
| Recall number | Z-0303-2021 |
| 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 II recall — Microbiologics Inc (Z-0303-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86576/
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