Z-0846-2014Class II

Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay...

Name: Z-0846-2014 Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay...
Creator: Focus Diagnostics Inc
Published: 2014-01-10
License: https://open.fda.gov/license/

DiaSorin Molecular LLC / initiated 2014-01-10 / Terminated

FDA source

Focus Diagnostics Inc began a recall of 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... on 2014-01-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0846-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-10
Posted: 2014-01-28
Terminated: 2014-10-15
Recalling firm: DiaSorin Molecular LLC
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 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.
Product code: OCC Respiratory Virus Panel Nucleic Acid Assay System
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.
FDA root cause: Pending
Action: Focus Diagnostics sent an Urgent Safety Notice Correction letter dated January 10, 2014, via email and a hard copy letter by mail. The letter informed customers of the correction, product description with codes, product intended use, issue, risk to health, background, recommendation, actions by customers, and contact information. Customers were instructed to check their inventory for the affected product, if customers detect any positive RSV results, confirm the positive result by an alternate method. Customers were asked to complete the "URGENT: SAFETY NOTICE Acknowledgement and Receipt Form Response Required". Customers with questions were instructed to contact their Technical Services department at 800-838-4548, select option 3. For questions regarding this recall call 714-220-1900.
Quantity in commerce: 1,052 kits
Distribution: 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. .
Product codes and lots: Model Number MOL2650 Lot Numbers: 24493, 24495, 24535, 24536.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0846-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0846-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-28

Product code OCC

K120413Class IISimplexa Flu A/b & Rsv Direct, Simplexa Flu A/b & Rsv Positive Control PackFocus Diagnostics, Inc. / cleared 2012-07-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)