Quidel Cardiovascular Inc.
San Diego, CA, US
Quidel Cardiovascular Inc. appears in FDA device records in San Diego, CA. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Quidel Cardiovascular Inc. between 2019 and 2020. The busiest year on record is 2019, with 1. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 1 |
| 2020 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013982035 | 3013982035 | Quidel Cardiovascular Inc. | 9975 Summers Ridge Road, San Diego, CA 92121 US | 2026 | and 10 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DIFDrug Mixture Control Materials
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- JXOEnzyme Immunoassay, Cocaine
- DJREnzyme Immunoassay, Methadone
- DJGEnzyme Immunoassay, Opiates
- GHHFibrin Split Products
- DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- KHOFluorometer, For Clinical Use
- JHXFluorometric Method, Cpk Or Isoenzymes
- LAFGas Chromatography, Methamphetamine
- MMIImmunoassay Method, Troponin Subunit
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- DDRMyoglobin, Antigen, Antiserum, Control
- PZNPlacental Growth Factor Test
- LFGRadioimmunoassay, Tricyclic Antidepressant Drugs
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- NBCTest, Natriuretic Peptide
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1974-2023 | Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL. Lots T13664 - T14045. | Raw material issue may cause cardiac panel products to have an average of 30% troponin signal reduction across measurement range 0.05 ng/mL to 30 ng/mL, QC testing won't detect anomaly, so an alternate method is recommended, if unavailable, use recommendations to mitigate potential patient impact, which could be missed/delayed myocardial infarction diagnosis. | Class I | Open, Classified | |
| Z-1552-2020 | Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box. Quidel Cardiovascular Inc. 9975 Summers Ridge Road San Diego, CA 92121 USA Quidel.com | Due to an error in the programming of the Control CODE CHIP module for this lot, a failing result is inappropriately displayed for AMP and mAMP. This issue results in the Triage Meter displaying a failing control result for the AMP and mAMP tests when the control did not fail. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain