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U.S. Department of Health and Human Services

Class 2 Device Recall Legionella IFA

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  Class 2 Device Recall Legionella IFA see related information
Date Initiated by Firm February 15, 2017
Date Posted March 27, 2017
Recall Status1 Terminated 3 on April 13, 2017
Recall Number Z-1685-2017
Recall Event ID 76619
Product Classification Reagents, antibody, legionella, direct & indirect fluorescent - Product Code LHL
Product Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
Code Information Unique Device Identifier IF0950: 20816101020045, lot numbers 30244, 30928, 31288, 31642, 32331, 32562, 32850
Recalling Firm/
Manufacturer		 Focus Diagnostics Inc
11331 Valley View St
Cypress CA 90630-5366
For Additional Information Contact Jennifer Hessel
510-240-6500
Manufacturer Reason
for Recall		 After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Legionella IFA device (IF0950) is not 510(k) exempt.
FDA Determined
Cause 2		 No Marketing Application
Action Focus Diagnostics/DiaSorin Molecular is issuing a medical device correction for the Legionella IFA (Immuno Fluoresence Assay). On February 1, 2017, the firm was notified that the Legionella IFA was not properly classified according to 21 CFR Part 807. The product is being withdrawn from the market. Use of the product should be immediately discontinued, and any remaining inventory should be immediately destroyed. The firm sent notice to its consignees, which should be reviewed with the facility's laboratory or mediclal director. Patient results obtained with all lots of the affected product should be evaluated by the clinician and if recommended, retested by another method.
Quantity in Commerce 196 units
Distribution Product was distributed to three testing laboratories in California, New Jersey and Virginia
Total Product Life Cycle TPLC Device Report
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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