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U.S. Department of Health and Human Services

Class 2 Device Recall FreeStyle Connect

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  Class 2 Device Recall FreeStyle Connect see related information
Date Initiated by Firm February 17, 2006
Date Posted March 15, 2006
Recall Status1 Terminated 3 on January 20, 2011
Recall Number Z-0604-06
Recall Event ID 34665
510(K)Number K051802  
Product Classification System, Test, Blood Glucose, Over The Counter - Product Code NBW
Product FreeStyle Connect Point of Care Blood Glucose Monitoring System, including Control Solutions and Test Strips;
Part Number: 70672-01;

Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Code Information All lots, including: FC0010, FC0012, FC0013, FC0014, FC0015, FC0016, FC0017, FC0020, FC0019, FC0018, FC0021, FC0022, FC0023, FC0026, FC0024, FC0025, FC0027, FC0028, FC0029, FC0030, FC0031, FC0032, FC0033, FC0034, FC0036  
Recalling Firm/
Manufacturer		 Abbott Diabetes Care, Inc.
1360 South Loop Road
Alameda CA 94502-7000
For Additional Information Contact Tina Mazurkiewicz
510-749-6333
Manufacturer Reason
for Recall		 The device may give inaccurate elevated blood glucose test results. This may lead to over treatment and hypoglycemic complications may result.
FDA Determined
Cause 2		 Other
Action On 2/17/06 the firm initiated the recall via its reps and on 2/22/06 notification was via letters explaining the reason for the recall and reporting that its reps will replace the units.
Quantity in Commerce 900
Distribution The product was released for distribution to 28 consignees in US. The recall was appropriately extended to the consumer/user level; i.e., the physicians and hospitals who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian 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 = NBW and Original Applicant = ABBOTT DIABETES CARE INC.
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