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QuickVue
QUIDEL CORPORATION · Model 0B006 · UDI-DI 30014613200062
LJC
Prescription
1
510(k) clearances
25
Adverse events
7
Recalls
10
Facilities
Description
QkVue Chlamydia 25T
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2011-07-08 | bioMerieux, Inc. | Complaints were received of high rates of false positive results, leading to unnecessary antibiotic therapy being prescribed to patients. |
| 2008-08-27 | Calbiotech Inc | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, |
| 2008-08-27 | Calbiotech Inc | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, |
| 2003-08-06 | bioMerieux | Product's decrease in sensitivity may result in false negative results |
| 2003-02-07 | Thermo Biostar, Incorporated | Chlamydia IVD test kits may contain diluted conjugate reagent. Use may produce a false negative result with a low positive patient sample. |
| 2003-02-07 | Thermo Biostar, Incorporated | Chlamydia IVD test kits may contain diluted conjugate reagent. Use may produce a false negative result with a low positive patient sample. |
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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.