Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 20, 2013
Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Quidel Corporation recalled Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic. - a moderate-severity action.
Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic. was recalled by Quidel Corporation in February 20, 2013. Reason: Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits beca…. Check the official notice for the remedy. Verify recall #Z-0819-2013 with the FDA Devices before acting.
The recall
Quidel Corporation issued this moderate-severity FDA Devices recall-Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits beca….
- Moderate
- severity level
- Class II
- classification
- February 20, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0819-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0819-2013) was formally reported on February 20, 2013, with the manufacturer initiating the action on December 3, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Quidel Corporation is listed as the recalling firm, operating out of San Diego, CA. Federal records list the affected scope as 13,090 kits (327,250 tests).
The documented reason for this recall is: 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 data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and internationally to Korea, Norway, Germany, Chile, Hong Kong, Switzerland, Netherlands, Thailand, Japan, China, and the UK. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
13,090 kits (327,250 tests)
Related Recalls
6
3 from same agency
Product description
Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0819-2013 |
| Date reported | February 20, 2013 |
| Date initiated | December 3, 2012 |
| Recalling firm | Quidel Corporation |
| Firm location | San Diego, CA |
| Affected scope | 13,090 kits (327,250 tests) |
| Distribution | Worldwide Distribution - USA (nationwide) and internationally to Korea, Norway, Germany, Chile, Hong Kong, Switzerland, Netherlands, Thailand, Japan, China, and the UK |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0819-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.. Recalled by Quidel Corporation. Units affected: 13,090 kits (327,250 tests).
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on February 20, 2013. Severity: Moderate. Recall number: Z-0819-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and internationally to Korea, Norway, Germany, Chile, Hong Kong, Switzerland, Netherlands, Thailand, Japan, China, and the UK.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0819-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 20, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.