CLASS II Device recall · Reported 5 Feb 2014 · FDA Enforcement Report
Simplexa Flu A/B & RSV Direct assay recalled by Focus Diagnostics
Focus Diagnostics is recalling Simplexa Flu A/B & RSV Direct assay, distributed nationwide in the US. The recall was initiated on 10 Jan 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0846-2014
- FDA event ID
- 67213
- Recalling firm
- Focus Diagnostics, Cypress, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jan 2014
- FDA classified
- 28 Jan 2014
- Reported
- 5 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Device type
- CPAP & Ventilators
Timeline
| 10 Jan 2014 | Recall initiated by company | |
| 28 Jan 2014 | Classified by FDA | +18 days |
| 5 Feb 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Focus Diagnostics is initiating an urgent safety notice correction for Simplexa Flu A/B & RSV Direct assay (MOL2650) because Focus Diagnostics has received some customer complaints of Simplexa Flu A/B & RSV lots due to sporadic false positive RSV signals, which may result in a higher RSV false positive rate.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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 respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is 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.
Where it was distributed
Worldwide Distribution - US (Nationwide) including states of: NY, MA, NJ, OH, CA, HI, CO, MN, FL, PA, IA, WI, AZ, TX, TN, IL, SD, MO, NM, AR, WV, MI and Internationally to: Sweden, Israel, Canada, and Slovenia. .
Nationwide ArkansasArizonaCaliforniaColoradoFloridaHawaiiIowaIllinoisMassachusettsMichiganMinnesotaMissouriNew JerseyNew MexicoNew YorkOhioPennsylvaniaSouth DakotaTennesseeTexas
Questions about this recall
Is Simplexa Flu A/B & RSV Direct assay recalled?
Yes. Focus Diagnostics recalled Simplexa Flu A/B & RSV Direct assay on 10 Jan 2014. The recall is Class II and its status is Terminated. Recall number Z-0846-2014.
Why was it recalled?
Focus Diagnostics is initiating an urgent safety notice correction for Simplexa Flu A/B & RSV Direct assay (MOL2650) because Focus Diagnostics has received some customer complaints of Simplexa Flu A/B & RSV lots due to sporadic false positive RSV signals, which may result in a higher RSV false positive rate.
Which lots are affected?
Model Number MOL2650 Lot Numbers: 24493, 24495, 24535, 24536.
Where was it sold?
Worldwide Distribution - US (Nationwide) including states of: NY, MA, NJ, OH, CA, HI, CO, MN, FL, PA, IA, WI, AZ, TX, TN, IL, SD, MO, NM, AR, WV, MI and Internationally to: Sweden, Israel, Canada, and Slovenia. .
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Focus Diagnostics
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|---|---|---|---|---|---|
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