Recall Z-1941-2014 ยท OMN C. Difficile Nucleic Acid Amplification Test Assay
Meridian Bioscience Inc
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.
| Date | Jun 27, 2014 (initiated Apr 22, 2014) |
| Status | Terminated |
| Reason | Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration. |
| Root cause | Employee error |
| Action | Meridian sent an Urgent Medical Device Recall letter dated April 25, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately return their unit to Meridian Bioscience. Meridian's Technical Support Staff will call them directly to provide them with a return authorization number and instructions for decontaminating, packaging and shipping the unit. For additional information customers were instructed to call 800-343-3858 (North America or 513-271-3700 (Worldwide). |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110012 | ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10 Meridian Bioscience, Inc., Feb 24, 2011 |