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U.S. Department of Health and Human Services

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

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 Class 2 Recall
Simplexa Flu A/B &38; RSV Direct assay
see related information
Date Posted March 05, 2014
Recall Status1 Open
Recall Number Z-1144-2014
Recall Event ID 67436
Premarket Notification
510(K) Number
K120413 
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, California 90630-5366
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
OTHER/UNDETERMINED: Pending
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 United States.Canada.Sweden. Belgium. Spain. Portugal. Slovenia. Israel.

 
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.
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