Quidel Corp.
United StatesFDA applicant, unverified FDA FEI 2024674
Quidel Corp. is a medical device manufacturer, with 214 devices listed in 4 registries (FDA Class II, Class I, Unclassified and Class III) and 15 FDA recalls as of 13 Nov 2026.
- Devices
- 214
- Registrations
- FDA
- FDA recalls
- 156 ongoing
Registry facts
- Registries
- FDA 510(k) 130
- FDA GUDID 83
- EUDAMED 31
- FDA PMA 1
- Device classes
- FDA Class II 127
- FDA Class I 80
- FDA Unclassified 5
- FDA Class III 1
- FDA recalls
- Identifiers
- FDA FEI 2024674
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Quidel Corp. makes
Quidel Corp. manufactures in vitro diagnostic (IVD) test kits and analysers for detecting various biomarkers and pathogens. These include rapid immunochromatographic test (ICT) kits for Group A Streptococcus, human chorionic gonadotropin (hCG), respiratory syncytial virus (RSV), influenza A/B, faecal occult blood, and SARS-CoV-2 antigens, as well as fluorescent immunoassay-based tests for Group A Streptococcus and point-of-care fluorescent immunoassay analysers.
The company's devices span Class I, Class II, and Class III regulatory classifications and are listed in the FDA’s 510(k), PMA, and UDI databases.
Catalogue
Search and filter all 214 devicesShowing 1-50 of 214
Company details
- FDA FEI number
- 2024674
- Address
- 10165 MCKELLAR CT., SAN DIEGO, CA, 92121
FDA recalls
FDA recall records list 15 recalls initiated by Quidel Corp., the earliest on 2010-11-23 and the most recent on 2026-04-06. By recorded status: 6 ongoing and 9 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 3
- 2018 0
- 2019 0
- 2020 2
- 2021 2
- 2022 0
- 2023 1
- 2024 3
- 2025 1
- 2026 1
2026
- 6 Apr 2026 Z-2169-2026 Class II Ongoing Product has the potential for false positive results
2025
- 17 Jun 2025 Z-2545-2025 Class II Ongoing Dipstick strep A test has potential for false positive results.
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- 17 Jun 2025 Z-2545-2025 Class II Ongoing Dipstick strep A test has potential for false positive results.
2024
- 5 Mar 2024 Z-1636-2024 Class II Ongoing There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/ hidden under the cassette of the test device thus potentially leading to a false negative result.
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- 5 Mar 2024 Z-1637-2024 Class II Ongoing There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/ hidden under the cassette of the test device thus potentially leading to a false negative result.
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- 3 Jan 2024 Z-1086-2024 Class II Ongoing One lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with incorrect expiration dates. The kits contain pouched cassettes labeled with an expiration date of May 31, 2025, however the correct expiration date for the pouches is September 12, 2024. The kits are labeled with an expiration date of April 30, 2025, however, the correct expiration date for the kits is September 12, 2024. The issue was discovered on November 28, 2023 by a supply chain employee who determined that the kits had expiration dates beyond the FDA authorized shelf life.
- 5 Mar 2024 Z-1636-2024 Class II Ongoing There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/ hidden under the cassette of the test device thus potentially leading to a false negative result.
2023
- 1 Feb 2023 Z-1308-2023 Class II Ongoing Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.
2021
- 13 Aug 2021 Z-2477-2021 Class II Terminated Revised Instructions for Use: Potential for specimens from patients with high SARS-CoV-2 viral loads to be falsely interpreted as negative if target amplification occurs prior to a cycle-threshold (Ct) value of 5 when using the Thermo Fisher QuantStudio 7 Pro, the Applied Biosystems 7500 Fast Dx, the Applied Biosystems 7500, the Bio-Rad CFX96 Touch", the Roche LightCycler LC 480 II/ cobas z 480, or the Qiagen Rotor-Gene MDx.
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- 27 Apr 2021 Z-1928-2021 Class I Terminated In rare situations patients infected with high viral load of SARS CoV 2 may have samples that generate Ct values less than or equal to (d) 5 when certain amplification and detection platforms (thermocyclers) are used. These specimens would be falsely interpreted as negative if target amplification occurs prior to a cycle threshold (Ct) value of 5. There have been no formal complaints of False Negative results with Ct values <5 from Lyra SARS-CoV-2 Assay users.
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- 13 Aug 2021 Z-2477-2021 Class II Terminated Revised Instructions for Use: Potential for specimens from patients with high SARS-CoV-2 viral loads to be falsely interpreted as negative if target amplification occurs prior to a cycle-threshold (Ct) value of 5 when using the Thermo Fisher QuantStudio 7 Pro, the Applied Biosystems 7500 Fast Dx, the Applied Biosystems 7500, the Bio-Rad CFX96 Touch", the Roche LightCycler LC 480 II/ cobas z 480, or the Qiagen Rotor-Gene MDx.
2020
- 25 Sep 2020 Z-0428-2021 Class II Terminated Due to false positive results.
- 17 Sep 2020 Z-0124-2021 Class II Terminated Instructions for use in the package insert for SARS Antigen FIA test were updated to remove all references to a specific viral transport medium product as well as the use of other viral transport media. Use of the specific viral transport medium products may result in False-positive results. Directly testing from specimens (NS or NP swab) is recommended.
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Show all 15 recalls
2017
- 15 Dec 2017 Z-1183-2018 Class II Terminated The calibration for the affected batch of analyzers was incorrectly set during the manufacturing process which may lead to a failure when calibration is first performed. There may also be e remote possibility that incorrect qualitative test results for patient samples near the assay cutoff may be reported.
- 22 Jun 2017 Z-2803-2017 Class II Terminated In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors.
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- 25 Jan 2017 Z-1231-2017 Class II Terminated Quidel Corporation is recalling Influenza Transport Swab Packages because it may include an incorrect sample swab mixed in with the proper swabs.
2012
- 3 Dec 2012 Z-0819-2013 Class II Terminated Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits because of false positive results which may lead to misdiagnosis.
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- 3 Dec 2012 Z-0819-2013 Class II Terminated Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits because of false positive results which may lead to misdiagnosis.
2010
- 23 Nov 2010 Z-1457-2011 Unclassified (pre-2012) Terminated The recall was initiated after Quidel Corporation determined that a small number of QuickVue One-Step hCG Urine kits have been incorrectly packaged with QuickVue H. pylori gll cassettes inside the kit boxes. These foil pouches and test
cassettes are clearly labeled as H. pylori. Nevertheless, there is a risk that customers may overlook this labeling.
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- 23 Nov 2010 Z-1457-2011 Unclassified (pre-2012) Terminated The recall was initiated after Quidel Corporation determined that a small number of QuickVue One-Step hCG Urine kits have been incorrectly packaged with QuickVue H. pylori gll cassettes inside the kit boxes. These foil pouches and test
cassettes are clearly labeled as H. pylori. Nevertheless, there is a risk that customers may overlook this labeling.
Frequently asked questions
How many devices does Quidel Corp. have in the registry?
The registry currently lists 214 devices for Quidel Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Quidel Corp.'s devices?
Among its 50 most recently registered devices, Quidel Corp. has devices listed in EUDAMED (14 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Quidel Corp.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Quidel Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Quidel Corp.?
FDA recall records list 15 recalls initiated by Quidel Corp., the most recent initiated on 6 Apr 2026. 6 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Quidel Corp. in the registry?
The most recently registered devices listed for Quidel Corp. include QuickVue 20125, Sofia 20253, AmpliVue Group A Strep Assay and MicroVue C1-Inhibitor.