Food, drugs, devices › Meridian Bioscience Inc
Device recall: illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader is designed to be used with i
FDA enforcement event 68396 is a device recall by Meridian Bioscience Inc of Cincinnati, OH, initiated 22 Apr 2014 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 30 Jun 2014. Initiation: voluntary: firm initiated. Meridian Bioscience Inc has 11 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Meridian Bioscience Inc, Cincinnati, OH.
Reason for recall
"Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration."
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1941-2014 | 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. | 35 instruments | Class II | Terminated | 9 Jul 2014 |
Context
Other enforcement events for Meridian Bioscience Inc
All 11 events for Meridian Bioscience Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 30 Jun 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.