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AmpliVue
QUIDEL CORPORATION · Model C. difficile Assay · UDI-DI 30014613312017
OZN
Prescription
10
510(k) clearances
31
Adverse events
8
Recalls
13
Facilities
Description
AmpliVue CDiff Assay
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-05 | Meridian Bioscience Inc | The affected lots show a decline in performance over time, which may lead to false-negative results. |
| 2025-09-23 | Becton Dickinson & Co. | Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials ar |
| 2024-10-31 | Becton Dickinson & Co. | BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product serv |
| 2023-06-05 | Luminex Corporation | It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) co |
| 2022-06-17 | Luminex Corporation | There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab. |
| 2019-02-20 | Luminex Corporation | Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially |
| 2013-10-16 | Nanosphere, Inc. | Nanosphere has received report of an increased rate of "No Call - INT CTL 2" results for the Internal Control 2 (INT CTL 2) when negative samples are tested with certain lots of CD |
| 2013-10-10 | Nanosphere, Inc. | Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies f |
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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.