Quidel Recalls Sofia Influenza A+B FIA Kits Due to False Positives
Quidel is voluntarily recalling specific lots of Sofia Influenza A+B FIA kits because they may produce false positive results, potentially leading to misdiagnosis.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves false positive results leading to misdiagnosis, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits. The recall is being conducted because the kits may produce false positive results, which could lead to misdiagnosis of patients.
The affected product is the Quidel Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), an in vitro diagnostic. The recall covers 13,090 kits, totaling 327,250 tests. The affected lot numbers range from 208228-214385 and 707916-708108, comprising 29 lots.
These kits were distributed nationwide in the United States and internationally to Korea, Norway, Germany, Chile, Hong Kong, Switzerland, Netherlands, Thailand, Japan, China, and the UK. Healthcare providers and laboratories should check their inventory for these specific lot numbers and stop using the affected kits immediately.
The recalled product
- Product
- Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.
- Manufacturer
- Quidel Corporation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # Range: 208228-214385
- 707916-708108 (29 lots).
Distribution
Distributed nationwide across the United States.
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