Class II — Meridian Bioscience Inc
| Recalling firm | MERIDIAN BIOSCIENCE, INC. |
|---|---|
| Registered facility | MERIDIAN BIOSCIENCE, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration. |
| Product | illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader is designed to be used with illumigene Molecular Assays. The device incubates illumigene Test Devices and reads endpoint reactions. |
| Quantity | 35 instruments |
| Distribution | Worldwide Distribution - USA including AL, AZ, CA, CO, FL, IA, IN, LA, MA, ME, MI, MN, NJ, NY, OH, PA, and WV. Internationally to Australia. |
| Initiated | 2014-04-22 |
| Classified | 2014-06-27 |
| Terminated | 2014-06-30 |
| Recall number | Z-1941-2014 |
| 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 — Meridian Bioscience Inc (Z-1941-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68396/
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