Home › MERIDIAN BIOSCIENCE, INC. › Alethia™ C. difficile External Control Kit
Alethia™ C. difficile External Control Kit
MERIDIAN BIOSCIENCE, INC. · Model 479920 · UDI-DI 00840733102134
OMN
Prescription
5
510(k) clearances
0
Adverse events
2
Recalls
5
Facilities
Description
The Alethia™ C. difficile External Control Kit contains Positive and Negative Control Reagents for use with the Alethia™ 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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.