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U.S. Department of Health and Human Services

Class 2 Device Recall Clearview iFOB Return Mailer (accessory)

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  Class 2 Device Recall Clearview iFOB Return Mailer (accessory) see related information
Date Initiated by Firm March 21, 2011
Date Posted April 28, 2011
Recall Status1 Terminated 3 on March 07, 2013
Recall Number Z-2111-2011
Recall Event ID 58407
510(K)Number K063693  
Product Classification Reagent, occult blood - Product Code KHE
Product Clearview¿ iFOB, Clearview¿ - Clearview iFOB Return Mailer(accessory)
Product Part Number:
8117KCV
Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices
Code Information Lot Numbers:  0630110
Recalling Firm/
Manufacturer		 Alere North Americal
30 S Keller Rd Ste 100
Suite 100
Orlando FL 32810-6297
Manufacturer Reason
for Recall		 Potential for false negatives test results and negative/faint positive controls
FDA Determined
Cause 2		 Other
Action Alere sent a Voluntary Product Recall letter dated March 21, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to indicate zero on the attached Recall Reply Form, sign, and fax to 1-877-877-0147, if they have no remaining product. For any remaining product customers were instructed to discontinue use and indicate the quantity of kits in the attached Recall Reply Form so that the firm can arrange for them to receive credit. Customers were instructed to destroy any affected units at their site. For any further distribution of product, customers will need to be contacted. Physicians and hospitals were advised to retest patients with negative results. Questions relating to this Voluntary Product Recall call 1-877-597-9586.
Quantity in Commerce 500 units
Distribution Nationwide Distribution
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.
510(K) Database 510(K)s with Product Code = KHE and Original Applicant = NEW BAY BIORESEARCH CO. LTD.
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