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illumigene C. difficile External Control Kit
MERIDIAN BIOSCIENCE, INC. · Model 279920 · UDI-DI 00840733101120
OMN
Prescription
5
510(k) clearances
0
Adverse events
2
Recalls
5
Facilities
Description
The illumigene C. difficile External Control Kit contains Positive and Negative Control Reagents for use with the illumigene C. difficile test kit. External controls are used as part of a routine quality control program.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-07 | Meridian Bioscience Inc | The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume. |
| 2014-04-22 | Meridian Bioscience Inc | Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration. |
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