Focus Diagnostics Recalls Simplexa Flu A/B & RSV Direct Assay Kits
Focus Diagnostics is recalling 1,052 Simplexa Flu A/B & RSV Direct assay kits due to sporadic false positive RSV signals that may lead to incorrect diagnostic 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 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, and the hazard involves a risk of harm (incorrect diagnosis) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Focus Diagnostics Inc is initiating an urgent safety notice correction for the Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The recall involves 1,052 kits with lot numbers 24493, 24495, 24535, and 24536. This in vitro diagnostic test is intended for use on the 3M Integrated Cycler instrument to detect and differentiate influenza A, influenza B, and respiratory syncytial virus (RSV) RNA in human nasopharyngeal swabs.
The recall was initiated because Focus Diagnostics received customer complaints regarding sporadic false positive RSV signals in the affected lots. These false positives may result in a higher RSV false positive rate, potentially leading to incorrect diagnostic conclusions for patients with respiratory tract infections.
The affected products were distributed nationwide in the United States, including states such as NY, MA, NJ, OH, CA, HI, CO, MN, FL, PA, IA, WI, AZ, TX, TN, IL, SD, MO, NM, AR, and WV. The kits were also distributed internationally to Sweden, Israel, Canada, and Slovenia. Healthcare facilities and laboratories should stop using the affected lots and contact Focus Diagnostics for further instructions.
The recalled product
- Product
- Simplexa Flu A/B & RSV Direct assay, Model MOL2650. 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 differentiation of influenza A virus, influenza B virus, and…
- Manufacturer
- Focus Diagnostics Inc
- Affected units
- 1,052
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 (4)
- Model Number MOL2650 Lot Numbers: 24493
- 24495
- 24535
- 24536.
Distribution
Related recalls
Same manufacturer · Focus Diagnostics Inc
See all →- LowFocus Diagnostics Legionella IFA Recalled for Regulatory Status Error
FDA (Devices) · 2017-04-05
- ModerateFocus Diagnostics Legionella IFA Substrate Slide Recalled for Regulatory Status
FDA (Devices) · 2017-04-05
- SevereFocus Diagnostics Recalls Simplexa Group A Strep Direct Amplification Discs
FDA (Devices) · 2016-04-13
- HighFocus Diagnostics Recalls Simplexa Direct Amplification Discs for Diagnostic Errors
FDA (Devices) · 2016-04-13
- SevereFocus Diagnostics Recalls Simplexa HSV 1&2 Direct Amplification Discs
FDA (Devices) · 2016-04-13
Same hazard · false positive
See all →- HighAlere San Diego Recalls hCG Urine Pregnancy Tests for False Positives
FDA (Devices) · 2026-10-07
- HighHealthmark ProChek-II Medical Tests Recalled for Expired Ingredient
FDA (Devices) · 2026-09-02
- HighAmyloid 1-42-N plasma cartridges recalled over falsely elevated results
FDA (Devices) · 2026-02-11
- HighpTau 217 plasma cartridges recalled over falsely elevated ratio results
FDA (Devices) · 2026-02-11
- HighAmyloid plasma controls recalled over falsely elevated ratio results
FDA (Devices) · 2026-02-11
Similar recalls
- ModerateFocus Diagnostics Recalls Simplexa Flu A/B & RSV Direct Assay Kits
FDA (Devices) · 2014-07-09
- ModerateFocus Diagnostics Recalls Simplexa Flu and RSV Assay Kits
FDA (Devices) · 2014-03-12
- HighSimplexa Flu A/B & RSV Diagnostic Kits Recalled for Leaking Components
FDA (Devices) · 2023-03-15
- HighFocus Diagnostics Recalls Simplexa Direct Amplification Discs for Diagnostic Errors
FDA (Devices) · 2016-04-13
- SevereFocus Diagnostics Recalls Simplexa HSV 1&2 Direct Amplification Discs
FDA (Devices) · 2016-04-13
- HighRoche Influenza A/B and RSV Test Kit Recalled for False Negative Results
FDA (Devices) · 2023-02-15