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U.S. Department of Health and Human Services

Class 2 Device Recall Simplexa Flu A/B &38; RSV Direct

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 Class 2 Recall
Simplexa Flu A/B &38; RSV Direct
see related information
Date Posted July 01, 2014
Recall Status1 Open
Recall Number Z-1958-2014
Recall Event ID 68347
Premarket Notification
510(K) Number
K120413 
Product Classification Respiratory Virus Panel Nucleic Acid Assay System - Product Code OCC
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.
Code Information 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.
Recalling Firm/
Manufacturer
Focus Diagnostics Inc
11331 Valley View St
Cypress, California 90630-5366
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: 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 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.
Quantity in Commerce 614 kits
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = OCC and Original Applicant = FOCUS DIAGNOSTICS, INC.
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