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U.S. Department of Health and Human Services

Class 2 Device Recall Simplexa" Flu A/B & RSV Direct assay

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 Class 2 Recall
Simplexa" Flu A/B & RSV Direct assay
see related information
Date Posted January 28, 2014
Recall Status1 Terminated on October 15, 2014
Recall Number Z-0846-2014
Recall Event ID 67213
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 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.
Code Information Model Number MOL2650 Lot Numbers: 24493, 24495, 24535, 24536.
Recalling Firm/
Manufacturer
Focus Diagnostics Inc
11331 Valley View St
Cypress, California 90630-5366
Manufacturer 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 Determined
Cause 2
PRODUCTION CONTROLS: Process Control
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 - USA including 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 Kamnick, Slovenia. .
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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