Focus Diagnostics Recalls Simplexa Flu A/B & RSV Direct Assay Kits
Focus Diagnostics is correcting labeling for 614 Simplexa Flu A/B & RSV Direct kits due to sporadic false signals that may increase false 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 involves a labeling correction for a diagnostic device where the hazard is potential false results rather than direct physical injury or death.
Plain-English summary
Focus Diagnostics Inc is issuing an urgent safety notice to correct the labeling for the Simplexa Flu A/B & RSV Direct assay (Model Number MOL2650). The recall involves 614 kits distributed nationwide with expiration dates ranging from October 31, 2014, to May 31, 2015.
The recall was initiated after the company received customer complaints regarding sporadic false signals in the assays. These signals may result in a higher rate of false results due to a potential issue with the software spectral matrix and the storage of the Direct Amplification Disc.
The Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs from human patients. The test is used as an aid in the differential diagnosis of these viral infections and is not intended to detect influenza C.
The recalled product
- Product
- Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 Simplexa" Flu A/B & RSV Direct. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and…
- Manufacturer
- Focus Diagnostics Inc
- Affected units
- 614
Distribution
Distributed nationwide across the United States.
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