Z-1958-2014Class II

Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 Simplexa" Flu A/B & RSV Direct. The...

Name: Z-1958-2014 Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 Simplexa" Flu A/B & RSV Direct. The...
Creator: Focus Diagnostics Inc
Published: 2014-05-15
License: https://open.fda.gov/license/

DiaSorin Molecular LLC / initiated 2014-05-15 / Terminated / root cause: design

FDA source

Focus Diagnostics Inc began a recall of 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... on 2014-05-15. FDA classified it as Class II and gives the reason as "Focus Diagnostics is providing an urgent safety notice for a correction to the labeling for Simplexa" Flu A/B & RSV Direct (MOL2650). Focus Diagnostics received some customer complaints of Simplexa Flu A/B & RSV Direct...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1958-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-15
Posted: 2014-07-01
Terminated: 2014-12-31
Recalling firm: DiaSorin Molecular LLC
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 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 providing an urgent safety notice for a correction to the labeling for Simplexa" Flu A/B & RSV Direct (MOL2650). Focus Diagnostics received some customer complaints of Simplexa Flu A/B & RSV Direct assays with sporadic false signals, which may result in a higher false results rate due to a potential software spectral matrix and Direct Amplification Disc storage.
Root cause tag: design
FDA root cause: Device Design
Action: Focus Diagnostics sent an Urgent Safety Notice Correction letter dated May 15, 2014, to all affected customers. The notification, informed customers of the product, the problem, and the action to be taken by the customer. To decrease the likelihood of obtaining any false results caused by either manually entering a spectral matrix or storing the DAD improperly after each use, please follow the recommended warnings and precautions provided in the revised and attached Simplexa Flu A/B & RSV Direct (PI.MOL2650 Rev. D) package insert. 1. The spectral matrix must be installed in each 3M Integrated Cycler and should not be changed unless an updated QR code for the instrument is provided by Focus Diagnostics. The spectral matrix is unique to each 3M Integrated Cycler. The spectral matrix was provided with the 3M Integrated Cycler instrument on the cover of the 3M Integrated Cycler Hardware Manual. If the matrix label will not scan or cannot be found, contact Focus Diagnostics. The contact information is on the last page of this document. 2. Not installing or changing the spectral matrix can result in false results. 3. After each use store DAD discs flat with the numbered foil side up. Customers were instructed to acknowledge that they have received this notification by signing the enclosed acknowledgement form and email the form to [email protected] or fax back to Focus Diagnostics Technical Services at 562-240-6526 within 10 business days. The Notice of Correction and Acknowledgement Form was sent to customers on 05/15/2014 via email and USPS mail. Additional customers were notified on 05/29/2014 via email and USPS mail. For questions regarding this recall call 714-220-1900.
Quantity in commerce: 614 kits
Distribution: Nationwide Distribution
Product codes and lots: Model Number: MOL2650. All Lot Numbers. The expiration date of the 614 kits of MOL2650 that are impacted by this Correction ranges from 10/31/2014 to 5/31/2015.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1958-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1958-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-01

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)