Food, drugs, devices › Quidel Corporation
Device recall: Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.
FDA enforcement event 64017 is a device recall by Quidel Corporation of San Diego, CA, initiated 3 Dec 2012 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. 88% of the 823 device enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 31 Jan 2014. 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
"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."
Distribution
"Worldwide Distribution - USA (nationwide) and internationally to Korea, Norway, Germany, Chile, Hong Kong, Switzerland, Netherlands, Thailand, Japan, China, and the UK"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0819-2013 | Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic. | 13,090 kits (327,250 tests) | Class II | Terminated | 20 Feb 2013 |
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: "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."
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: "Worldwide Distribution - USA (nationwide) and internationally to Korea, Norway, Germany, Chile, Hong Kong, Switzerland, Netherlands, Thailand, Japan, China, and the UK"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 31 Jan 2014. "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.