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U.S. Department of Health and Human Services

Class 2 Device Recall Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit

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  Class 2 Device Recall Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit see related information
Date Initiated by Firm October 02, 2015
Date Posted November 06, 2015
Recall Status1 Terminated 3 on January 29, 2016
Recall Number Z-0238-2016
Recall Event ID 72395
Product Classification Research use only/microbiology - Product Code OTT
Product Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.
Code Information 26341, 27011
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 is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results.
FDA Determined
Cause 2		 Device Design
Action A recall letter dated 10/2/15 was sent to distributors who distributed the Anaplasma phagocytophilum IFA IgM (IF1450M) kit lots 26431 and 27011. The letter informs the customers that Focus Diagnostics received customer complaints of IF1450M with low reactivity, which may result in higher invalid rate. The letter also provides the customers with Focus Diagnostics' recommendations and actions to be taken by the distributors. Customers with questions or require additional information are instructed to contact Focus Diagnostics' Technical Services department at (562) 240-6550 from 7am to 5pm (PST) or send an email to DxTS@focusdx.com.
Quantity in Commerce 38 kits
Distribution Non US (worldwide): Czech Republic, Denmark, Germany, Italy, Spain and Colombia
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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