Manufacturer
14 recalls in our database name Quidel Corporation as the manufacturing or recalling firm.
Of the 14 recalls from Quidel Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Quidel Corporation is recalling the QuickVue Dipstick Strep A Test (50T, REF 20108) due to the potential for false positive results. The product was distributed nationwide.
QuickVue Dipstick Strep A Tests are recalled because the test has the potential for false positive results. 22,470 units are affected.
Quidel InflammaDry MMP-9 test kits are recalled because the test results window is misaligned. Positive results may be hidden from view, potentially causing false negative readings.
Quidel Corporation is recalling 104,300 units of InflammaDry MMP-9 diagnostic tests due to misalignment of the test results window. Positive results may be hidden and not visible, potentially leading to false negative readings.
Quidel Corporation is recalling one lot of Sofia 2 Flu + SARS Antigen FIA diagnostic test kits due to incorrect expiration dates on packaging. Kits labeled to expire April 30 and May 31, 2025 actually expire September 12, 2024.
Quidel is recalling specific lots of MicroVue C1-Inhibitor Plus EIA test kits that may produce low optical density values and invalid test results.
The Lyra Direct SARS-CoV-2 assay can produce false negatives on certain PCR machines when specimens have high viral loads. Revised instructions address this diagnostic failure risk affecting approximately 81,910 kits distributed worldwide.
Quidel Corporation is recalling approximately 29,787 kits of the Lyra SARS-CoV-2 Assay due to a theoretical risk that samples with very high viral loads could produce false negative results. No false negatives have been formally reported.
Quidel is recalling 8,628 SARS Antigen FIA test kits due to false positive results. The affected units were distributed to 24 U.S. states.
Quidel Corporation is recalling package inserts for the Sofia SARS Antigen FIA test because instructions referencing specific viral transport media may lead to false-positive results.
Quidel is recalling 482 Sofia 2 Analyzers because a manufacturing error may cause calibration failure or incorrect test results.
Quidel Corporation is recalling InflammaDry sample collectors because in-house testing found plastic spurs at the tips of some units.
Quidel Corporation is recalling Influenza Transport Swab Packages because they may contain incorrect sample swabs mixed with the proper ones.
Quidel is voluntarily recalling specific lots of Sofia Influenza A+B FIA kits because they may produce false positive results, potentially leading to misdiagnosis.
Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.
Quidel
company
Source: Wikidata (Q15917582), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.