Meridian Bioscience Recalls illumipro-10 Incubator/Reader Units for Calibration Issues
Meridian Bioscience is recalling 35 illumipro-10 incubator/reader units because Block B chambers may operate at incorrect temperatures due to calibration errors.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The defect involves incorrect temperature calibration, which is a functional error rather than a direct physical hazard like fire or shock, and no injuries or illnesses are reported in the source text.
Plain-English summary
Meridian Bioscience, Inc. is recalling 35 illumipro-10 incubator/reader instruments. The recall is due to a defect where Block B chambers may operate at an incorrect temperature as a result of incorrect temperature calibration. The illumipro-10 is designed to be used with illumigene Molecular Assays to incubate test devices and read endpoint reactions.
The affected instruments were distributed worldwide, including in the United States (specifically AL, AZ, CA, CO, FL, IA, IN, LA, MA, ME, MI, MN, NJ, NY, OH, PA, and WV) and internationally to Australia. The recall covers specific serial numbers ranging from IP2669 to IP2706.
Users should check their instrument serial numbers against the list provided in the official recall notice. If the serial number matches, users should stop using the device and contact Meridian Bioscience for instructions on repair or replacement.
The recalled product
- 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.
- Manufacturer
- Meridian Bioscience Inc
- Affected units
- 35
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial Numbers: IP2669
- IP2670
- IP2671
- IP2672
- IP2673
- IP2674
- IP2675
- IP2676
- IP2677
- IP2678
- IP2680
- IP2682
- IP2683
- IP2684
- IP2685
- IP2686
- IP2687
- IP2688
- IP2689
- IP2690
Distribution
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