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U.S. Department of Health and Human Services

Class 1 Device Recall FreeStyle Blood Glucose Monitoring System

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 Class 1 Device Recall FreeStyle Blood Glucose Monitoring Systemsee related information
Date Initiated by FirmJune 07, 2005
Date PostedOctober 21, 2005
Recall Status1 Terminated 3 on May 17, 2006
Recall NumberZ-0054-06
Recall Event ID 33301
Product Classification System, Test, Blood Glucose, Over The Counter - Product Code NBW
ProductFreeStyle Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Code Information For lot numbers beginning with A, B, C, D, G, H, K, and M, all lot numbers are included. All lot numbers from V-G157-31584 and below are included, and also all lot numbers Y-G018-32983 and below are included in the recall.
Recalling Firm/
Manufacturer		 Abbott Laboratories Medisense Products
1360 S Loop Rd
Alameda CA 94502-7000
Manufacturer Reason
for Recall		User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
FDA Determined
Cause 2		Other
ActionThe firm has undertaken a field correction to notify their customers of the potential for the units of measure to be changed. The firm plans to (1) include a flyer in all Precision Xtra and FreeStyle meter kits to reinforce current labeling regarding units of measure and update the Frequently Asked Questions section of the website to reinforce the units of measure change, (2) Lock out the units of measure in new production meters to eliminate potential to change the units of measure settings, update the meter kits with a flyer to override the section of the manual indicating that the units of measure are changeable, and change the product insert in glucose test strips to indicate which units of measure are appropriate for the user and (3) update the labeling to indicate that the units of measure are not user configurable to eliminate the need for the flier.
DistributionApproximately 10,005,206 meters have been distributed worldwide since 1999, with 5,885,332 meters distributed in the US, and 4,517,211 in use.
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.
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