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
FDA Recall Z-0604-06 · Posted 2006-03-15
Recalling FirmAbbott Diabetes Care, Inc.
Recall StatusTerminated
Product CodeNBW
Date Initiated2006-02-17
Date Terminated2011-01-20
Product Quantity900
Reason for Recall
The device may give inaccurate elevated blood glucose test results. This may lead to over treatment and hypoglycemic complications may result.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.