FDA Device recall Z-0819-2013
Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic
- FDA Device
- Class II
- terminated
- Published 2013-02-20
On 2013-02-20 the FDA classified a Class II recall of Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic by Quidel, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0819-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-12-03 |
| Published | 2013-02-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Quidel |
| Distribution | US |
Product
Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.
Reason
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.
Identifiers
| code_info | Lot # Range: 208228-214385, 707916-708108 (29 lots). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0819-2013%22
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