Food, drugs, devices › Quidel Corporation
Device recall: QUIDEL Sofia SARS Antigen FIA IVD REF 20374
FDA enforcement event 86550 is a device recall by Quidel Corporation of San Diego, CA, initiated 25 Sep 2020 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 18 Sep 2024. Initiation: voluntary: firm initiated. Quidel Corporation has 13 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Quidel Corporation, San Diego, CA.
Reason for recall
"Due to false positive results."
Distribution
"U.S.: AL, AR, AZ, CA, FL, GA, IN, LA, MO, MS, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0428-2021 | QUIDEL Sofia SARS Antigen FIA IVD REF 20374 | 8,628 kits | Class II | Terminated | 18 Nov 2020 |
Context
Other enforcement events for Quidel Corporation
All 13 events for Quidel Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Due to false positive results."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "U.S.: AL, AR, AZ, CA, FL, GA, IN, LA, MO, MS, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 18 Sep 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.