Class II — Microbiologics Inc
| Recalling firm | Microbiologics, Inc. |
|---|---|
| Registered facility | Microbiologics, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing. |
| Product | KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299 |
| Quantity | 150 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Argentina, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia/Hrvatska, Ecuador, Finland, France, Germany, Guam, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Kenya, Republic of Korea, Latvia, Macedonia, Malaysia, Netherlands, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, South Africa, … |
| Initiated | 2014-10-06 |
| Classified | 2022-03-03 |
| Terminated | 2023-01-17 |
| Recall number | Z-0714-2022 |
| 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 II recall — Microbiologics Inc (Z-0714-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89451/
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