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U.S. Department of Health and Human Services

Class 3 Device Recall HemoSense INRatio2

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  Class 3 Device Recall HemoSense INRatio2 see related information
Date Initiated by Firm December 23, 2008
Date Posted May 22, 2009
Recall Status1 Terminated 3 on March 25, 2011
Recall Number Z-1256-2009
Recall Event ID 50695
510(K)Number K072727  
Product Classification Test, time, prothrombin - Product Code GJS
Product HemoSense INRatio2 Prothrombin Time Monitor, manufactured by HemoSense Incorporated.

The INRatio2 PT Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood.
Code Information Product Numbers: 0200431 and 0200432.
Recalling Firm/
Manufacturer		 HemoSense Inc
651 River Oaks Pkwy
San Jose CA 95134-1907
For Additional Information Contact
408-719-1393
Manufacturer Reason
for Recall		 INRatio Monitors that were manufactured with a specific EEPROM memory chip fail during use. The monitors report an error code and do not report a test result.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Letters for each product titled "Urgent: Medical Device Recall Notice" dated December 19, 2008 were issued explaining the problem and instructing users to discontinue use, complete the provided reply form and return the device by mail to Inverness Medical. Distributors of the violative device were instructed to contact their customers and provide the same recall information. Further questions should be addressed to HemoSense Technical Service at 1-877-441-7440.
Quantity in Commerce 921 units
Distribution Worldwide Distribution in the US, Germany, Spain and Australia.
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 = GJS and Original Applicant = HEMOSENSE, INC.
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