Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test… recallZ-0819-2013 · Quidel Corporation · initiated Dec 3, 2012
Class II Terminated All recalls posted in February 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Quidel Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Quidel Corporation sent a Medical Device Recall dated December 3, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product and remove the affected product from their inventory. Customers should contact Quide Corporation for instructions on how to obtain replacement product. Customers were instructed to fax the enclosed inventory Form to Quidel at 858-552-7905. For technical support customers should call 800-874-1517 or 858-552-1100. For questions regarding this recall call 858-552-1100, ext 7922.
Recall details
- Recall number
- Z-0819-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 3, 2012
- Posted by the FDA
- Feb 14, 2013
- Recalling firm
- Quidel Corporation
- Quantity
- 13,090 kits (327,250 tests)
- Product code
- GNX
- FDA submissions
- K112177
- Distribution
- Worldwide Distribution - USA (nationwide) and internationally to Korea, Norway, Germany, Chile, Hong Kong, Switzerland, Netherlands, Thailand, Japan, China, and the UK
Product description
Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.
Code information (models, lots, serial numbers)
Lot # Range: 208228-214385, 707916-708108 (29 lots).
Other devices under the same FDA submission
1 device cleared under K112177 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Sofia 20218Quidel Corporation · ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C1 death1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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