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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 Connectsee related information
Date Initiated by FirmFebruary 17, 2006
Date PostedMarch 15, 2006
Recall Status1 Terminated 3 on January 20, 2011
Recall NumberZ-0605-06
Recall Event ID 34665
510(K)NumberK013147 
Product Classification Single (Specified) Analyte Controls (Assayed And Unassayed) - Product Code JJX
ProductFreeStyle Connect Blood Glucose Test Strips; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502; Part Number: CAT70676-01
Code Information Lot Numbers: 0522524, 0526329, 0526326, 0529324, 0532203, 0533607, 0533641, 0534362, 0534404, 0534421, 0601135, 0601165, 0601608, 0601661  
Recalling Firm/
Manufacturer		 Abbott Diabetes Care, Inc.
1360 South Loop Road
Alameda CA 94502-7000
For Additional Information ContactTina 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
ActionOn 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 Commerce900
DistributionThe 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 CycleTPLC 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) Database510(K)s with Product Code = JJX
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