CLASS II Device recall · Reported 20 Feb 2013 · FDA Enforcement Report
Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit) recalled by Quidel
Quidel is recalling Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic, distributed nationwide in the US. The recall was initiated on 3 Dec 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0819-2013
- FDA event ID
- 64017
- Recalling firm
- Quidel, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Dec 2012
- FDA classified
- 14 Feb 2013
- Reported
- 20 Feb 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 3 Dec 2012 | Recall initiated by company | |
| 14 Feb 2013 | Classified by FDA | +73 days |
| 20 Feb 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.
Where it was distributed
Worldwide Distribution - USA (nationwide) and internationally to Korea, Norway, Germany, Chile, Hong Kong, Switzerland, Netherlands, Thailand, Japan, China, and the UK
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot # Range: 208228-214385, 707916-708108 (29 lots).
Where was it sold?
Worldwide Distribution - USA (nationwide) and internationally to Korea, Norway, Germany, Chile, Hong Kong, Switzerland, Netherlands, Thailand, Japan, China, and the UK
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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