Quidel Corporation

How does FDA spell Quidel Corporation?

FDA publishes this company under 5 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.

Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.

Which product codes does Quidel Corporation file in?

36 product codes, ranked by how much they file in each.

Showing the 25 they file in most, of 36.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

Has Quidel Corporation had a recall?

openFDA lists 15 recall records naming this company across its whole history, of which 1 was opened in the last 12 months and is not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.

• Z-2169-2026Class IIOpen, ClassifiedGTY6 April 2026

  Product has the potential for false positive results

• Z-2545-2025Class IIOpen, ClassifiedGTY17 June 2025

  Dipstick strep A test has potential for false positive results.

• Z-1636-2024Class IIOpen, ClassifiedPFQ5 March 2024

  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.

• Z-1637-2024Class IIOpen, ClassifiedPFQ5 March 2024

  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.

• Z-1086-2024Class IIOpen, ClassifiedQMN3 January 2024

  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.

Showing the 5 most recently initiated of 15.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved 2026-08-11T14:48:53Z

What has Quidel Corporation cleared recently?

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

Where is Quidel Corporation registered?

FDA lists 1 registered establishment for this company in US.

Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.