Recall Regarding Abbott FreeStyle Flash®, FreeStyle® Blood Glucose Meter and OmniPod Built in Meter

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Abbott Diabetes Care has issued a recall for the FreeStyle Blood Glucose Meter and the FreeStyle Flash Blood Glucose Meter. The recall was issued after the company discovered that FreeStyle Flash® and FreeStyle® Blood Glucose Meters may produce mistakenly low blood glucose results when using FreeStyle Lite® and FreeStyle® Blood Glucose Test Strips, which, if not recognized, may pose significant risks to patient’s health. FreeStyle and FreeStyle Flash Blood Glucose Meters have not been in production since 2010.

This issue affects not only the FreeStyle and FreeStyle Flash Blood Glucose Meters but also may affect the FreeStyle® blood glucose meter built into the OmniPod® Insulin Management System. 

No action is required if you do not use the meters pictured below.
  • FreeStyle Flash® Blood Glucose Meter
  • FreeStyle® Blood Glucose Meter

 

If you are currently using either of the meters pictured above, please take the following steps:

  1. Discontinue use of your FreeStyle Flash® or FreeStyle® Blood Glucose Meter and call Abbott Diabetes Care Customer Service at 1-888-345-5364. When you call, Abbott will send you a new FreeStyle® branded meter at no charge. 

    If the only meter you have available is a FreeStyle® or FreeStyle Flash® Blood Glucose Meter, do not stop testing your blood glucose. Control solution should be used to check the performance of your test strips and meter until you receive your replacement meter. However, if any reading from a strip appears lower than you would expect or does not seem to match the way you are feeling, you should contact your health care provider. Pay special attention to signs and symptoms of high blood sugar (hyperglycemia). 

    Symptoms of high blood sugar may include: Excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting, and abdominal pain. If you are experiencing any of these symptoms or are not feeling well, contact your health care professional immediately.

  2. Upon receiving your new replacement meter, please immediately dispose of your old meter in accordance with your local and state disposal regulations.

 

There are no other Abbott Diabetes Care products impacted by this issue.

 

Please take the following steps if you are using Omnipod Built in Meter:

 

  1. If you are using the FreeStyle® Blood Glucose Meter built into the OmniPod Personal Diabetes Manager (PDM), you must discontinue use of any FreeStyle® Blood Glucose Test Strips you may have until you obtain replacement strips from Abbott Diabetes Care. To receive replacement strips at no cost contact Abbott Diabetes Care Customer Service at 1-877-584-5159.
  2. Continue using your OmniPod Insulin Management System (OmniPod) to deliver your insulin therapy. While waiting for your replacement strips to arrive, use the FreeStyle® Freedom blood glucose meter that you may have previously received with your welcome pack. FreeStyle® test strips when used the FreeStyle® Freedom blood glucose meter will produce accurate blood glucose results. 

    If you would like to continue using the OmniPod system to recommend dosing, follow your OmniPod® Insulin Management System instructions for manually entering blood glucose readings. 

    As always, control solution should be used to check the performance of your test strips and meter until you receive your replacement test strips. If any reading from a strip appears lower than you would expect or does not seem to match the way you are feeling, you should contact your health care provider immediately. Pay special attention to signs and symptoms of high blood sugar (hyperglycemia). 

    Symptoms of high blood sugar may include: Excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting, and abdominal pain. If you are experiencing any of these symptoms or are not feeling well, contact your health care professional immediately.

  3. Abbott Diabetes Care will provide further information when you call on the process to obtain your test strips going forward. 

    FreeStyle® Blood Glucose Test Strips are the only strip type that is approved for use with your OmniPod® Insulin Management System. Please read your product information booklet and test strip insert carefully to ensure that you are using the correct test strip type for your OmniPod® Insulin Management system. OmniPod® Insulin Management System is not labeled for use with FreeStyle Lite® Blood Glucose Test Strips.

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