Focus Diagnostics Recalls Simplexa Flu and RSV Assay Kits
Focus Diagnostics is recalling Simplexa Flu A/B & RSV Direct Assay Kits due to the potential for false positive test results.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a potential for false positive results without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Focus Diagnostics Inc is recalling 2,175 units of the Simplexa Flu A/B & RSV Direct Assay Kits (Model Number MOL2650). The recall was initiated because the kits have the potential to produce false positive signals for Influenza A, Influenza B, and Respiratory Syncytial Virus (RSV).
The affected lots are 24493, 24495, 24535, 24536, 24591, 24603, 24605, 24732, 24773, 24788, 24797, and 24807. These kits were distributed nationwide in the United States and internationally to Canada, Sweden, Belgium, Spain, Portugal, Slovenia, and Israel.
The kits are intended to aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans. They are not intended to detect influenza C. Healthcare providers and laboratories should stop using the affected kits and contact the manufacturer for instructions on how to return them.
The recalled product
- Product
- Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650.
- Manufacturer
- Focus Diagnostics Inc
- Hazard
- Affected units
- 2,175
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 (12)
- Model Number MOL2650. Lot Numbers: 24493
- 24495
- 24535
- 24536
- 24591
- 24603
- 24605
- 24732
- 24773
- 24788
- 24797
- 24807.
Distribution
Distributed nationwide across the United States.
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