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U.S. Department of Health and Human Services

Class 2 Device Recall illumipro10 Incubator/Reader

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  Class 2 Device Recall illumipro10 Incubator/Reader see related information
Date Initiated by Firm April 22, 2014
Date Posted June 27, 2014
Recall Status1 Terminated 3 on June 30, 2014
Recall Number Z-1941-2014
Recall Event ID 68396
510(K)Number K110012  
Product Classification C. Difficile nucleic acid amplification test assay - Product Code OMN
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.
Code Information 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.
Recalling Firm/
Manufacturer		 Meridian Bioscience Inc
3471 River Hills Dr
Cincinnati OH 45244-3023
For Additional Information Contact Chris Ross
800-343-3858
Manufacturer 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 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OMN and Original Applicant = MERIDIAN BIOSCIENCE, INC.
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