Z-1941-2014Class II

illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader is designed to be...

Name: Z-1941-2014 illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader is designed to be...
Creator: Meridian Bioscience Inc
Published: 2014-04-22
License: https://open.fda.gov/license/

Meridian Bioscience Inc / initiated 2014-04-22 / Terminated / root cause: manufacturing process

FDA source

Meridian Bioscience Inc began a recall of illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader is designed to be used with illumigene Molecular Assays. The device... on 2014-04-22. FDA classified it as Class II and gives the reason as "Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1941-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-22
Posted: 2014-06-27
Terminated: 2014-06-30
Recalling firm: Meridian Bioscience Inc
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.
Product code: OMN C. Difficile Nucleic Acid Amplification Test Assay
Reason for recall: Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration.
Root cause tag: manufacturing process
FDA 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 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.
Product codes and 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1941-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1941-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-06-27

Product code OMN

K110012Class IIllumigene C. Difficile, and Illumipro-10Meridian Bioscience, Inc. / cleared 2011-02-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)