Class II — Microbiologics Inc
| Recalling firm | Microbiologics, Inc. |
|---|---|
| Registered facility | Microbiologics, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences). |
| Product | SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus. |
| Quantity | 218 |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of CA, FL, GA, IL, MD, MT, MN, NC, NY, NV, OR, TN, TX,UT, WA and WI. The countries of Austria, Canada, Colombia, France, Germany, Hong Kong, India, Ireland, Italy, Japan and United Kingdom. |
| Initiated | 2021-08-20 |
| Classified | 2021-09-17 |
| Terminated | 2023-01-12 |
| Recall number | Z-2486-2021 |
| 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-2486-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88577/
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