Date Initiated by Firm | February 17, 2006 |
Date Posted | March 15, 2006 |
Recall Status1 |
Terminated 3 on January 20, 2011 |
Recall Number | Z-0605-06 |
Recall Event ID |
34665 |
510(K)Number | K013147 |
Product Classification |
Single (Specified) Analyte Controls (Assayed And Unassayed) - Product Code JJX
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Product | FreeStyle 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
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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.
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Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = JJX
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