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

FDA device recall Z-1958-2014 · posted 2014-07-01 · Terminated

Recall details

Recalling firm

Focus Diagnostics Inc

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.

Action taken

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 DxTS@focusdx.com 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.

Root cause

Device Design

Status

Terminated

Product code

OCC

Quantity affected

614 kits

Distribution

Nationwide Distribution

Date initiated

2014-05-15

Date posted

2014-07-01

Date terminated

2014-12-31

Location

Cypress, CA

Related 510(k) clearances