Recall Z-1941-2014
Meridian Bioscience Inc · initiated April 22, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Serial Numbers: IP2669, IP2670, IP2671, IP2672, IP2673, IP2674, IP2675, IP2676, IP2677, IP2678, IP2680, IP2682, IP2683, IP2684, IP2685, IP2686, IP2687, IP2688, IP2689, IP2690, IP2691, IP2692, IP2693, IP2694, IP2695, IP2696, IP2697, IP2698, IP2699, IP2700, IP2701, IP2702, IP2703, IP2704, IP2705, IP2706.
Reason for recall
Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration.
FDA-determined cause: Employee error
Action taken
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).
Details
- Recall number
- Z-1941-2014
- Initiated
- April 22, 2014
- Posted by FDA
- June 27, 2014
- Terminated
- June 30, 2014
- Product code
- OMN – C. Difficile Nucleic Acid Amplification Test Assay
- 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.
- Recalling firm
- Meridian Bioscience Inc, Cincinnati, OH