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U.S. Department of Health and Human Services

Class 2 Device Recall Simplexa Flu A/B and; RSV Direct assay

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  Class 2 Device Recall Simplexa Flu A/B and; RSV Direct assay see related information
Date Initiated by Firm February 04, 2014
Date Posted March 05, 2014
Recall Status1 Terminated 3 on November 01, 2014
Recall Number Z-1144-2014
Recall Event ID 67436
Product Classification Respiratory virus panel nucleic acid assay system - Product Code OOC
Product Simplexa Flu AlB & RSV Direct Assay Kits, 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. Model Number MOL2650.
Code Information Model Number MOL2650. Lot Numbers: 24493, 24495, 24535, 24536, 24591, 24603, 24605, 24732, 24773, 24788, 24797, 24807.
Recalling Firm/
Manufacturer		 Focus Diagnostics Inc
11331 Valley View St
Cypress CA 90630-5366
For Additional Information Contact
714-220-1900
Manufacturer Reason
for Recall		 Focus Diagnostics initiated the recall of the certain Simplexa Flu AlB & RSV Direct assay kits due to the potential of false positive Flu A, Flu B and RSV signals.
FDA Determined
Cause 2		 Under Investigation by firm
Action Focus Diagnostic initiated this recall on February 4, 2014 by sending recall notification letters to customers via email. The letter dated February 4, 2014, titled "URGENT: SAFETY NOTICE REMOVAL", informed customers of the recall (removal). The letter provided the following information: product description with code, reason for recall, the issue, the risk to health, recommendation, background, actions by customers, contact information, labeling, and response sheet.
Quantity in Commerce 2,175 kits
Distribution Worldwide Distribution: US (nationwide) and to countries of:Canada, Sweden, Belgium, Spain, Portugal, Slovenia, and Israel.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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