FDAClass IIJuly 9, 2014

illumipro-10 Incubator/Reader recall

illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader is designed to be used with illumigene Molecular Assays.…

Why was illumipro-10 Incubator/Reader recalled?

Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader is designed to be used with illumigene Molecular Assays.…
Recalling firm
Meridian Bioscience Inc
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.
Recall date
July 9, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls