Recall Z-1941-2014— Meridian Bioscience Inc
Class II · Terminated
Class II FDA medical device recall by Meridian Bioscience Inc, initiated 2014-04-22, terminated 2014-06-30. It names one FDA 510(k) clearance: K110012. 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.. Reason: Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration..
- Recalling firm
- Meridian Bioscience Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-22
- Terminated
- 2014-06-30
- Firm location
- Cincinnati, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration.
Data sourced from openFDA. This site is unofficial and independent of the FDA.