Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.
FDA device recall Z-0819-2013 · posted 2013-02-14 · Terminated
Recall details
- Recalling firm
- Quidel Corporation
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GNX
- Quantity affected
- 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
- Date initiated
- 2012-12-03
- Date posted
- 2013-02-14
- Date terminated
- 2014-01-31
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOFIA ANALYZER AND INFLUENZA A+B FIA (K112177) | Quidel Corp. | 2011-10-24 |