Class III — Microbiologics Inc
| Recalling firm | Microbiologics, Inc. |
|---|---|
| Registered facility | Microbiologics, Inc. (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | The expiration date on the label of one component (negative control 0243U) in the set lot is incorrectly labeled. The KWIK-STIK negative control 0243U was labeled with an expiration date of 7/31/2020 when it should have been 7/31/2022. |
| Product | KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM) |
| Quantity | N/A |
| Distribution | US Nationwide distribution in the states of AL, CA, CO, IL, MD, MO, MS, NM, OH, OR, PA, TX, VT. |
| Initiated | 2020-12-16 |
| Classified | 2022-01-31 |
| Terminated | 2023-01-12 |
| Recall number | Z-0546-2022 |
| 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-0546-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89384/
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