Glucose Test Strips Recalled

Abbott Diabetes Care has initiated a recall of 359 lots—approximately 359 million strips—of <"">Precision Xtra®, Precision Xceed Pro®, MediSense® Optium™, Optium™, OptiumEZ, and ReliOn® Ultima Blood Glucose Test Strips in the United States and Puerto Rico the U.S. Food and Drug Administration (FDA) announced.

The test strips are used with Abbott’s Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, and OptiumEZ blood glucose monitoring systems. ReliOn Ultima test strips are used with the ReliOn Ultima blood glucose monitoring system. The blood glucose monitors are not being recalled and customers can continue using the blood glucose monitors.

The affected test strips may give falsely low blood glucose results, which can lead users to try to raise their blood glucose when it is unnecessary and to fail to treat elevated blood glucose due to a falsely low reading. The problem appears to be related to longer-than-expected blood fill times. This may be dependent on the age of the strips and if the strips have been stored in, or exposed to, higher temperatures—above 72°F and not to exceed 86°F—for an extended period of time.

Customers who have test strips from these affected lots should discontinue use of the product. Abbott Diabetes Care will replace affected test strips at no charge. Abbott Diabetes Care initiated this recall following a routine internal quality review that indicated certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima blood glucose test strips may experience longer-than-normal blood fill times which may cause falsely low blood glucose readings.

Customers are advised to contact their health care provider to determine testing options if they do not have any unaffected test strips to use. If consumers must use affected test strips while in the process of obtaining new strips, they should:

• Check the time it takes for the blood glucose meter to start the “countdown” after first applying blood to the test strip. Start timing immediately after blood first makes contact with the test strip. If the meter takes longer than five seconds to start the countdown, that test strip is affected and the result should not be used. Users should check the time for each test strip used because all of the strips in a package may not be affected to the same degree. If any reading appears lower-than-expected or does not seem to correlate with the way they are feeling, the user should contact their health care provider immediately.

• If a patient does not have immediate access to unaffected strips and is unable to test blood sugar, users need to be aware of symptoms of high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia).

High Blood Sugar Symptoms: Excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting, and abdominal pain. If a user is experiencing any of these symptoms or is not feeling well, they should contact their health care professional immediately.

Low Blood Sugar Symptoms: Trembling, excessive sweating, weakness, hunger, confusion, and headache. Some individuals may have no symptoms at all before developing unconsciousness or seizures. Low blood sugar must be treated promptly to avoid loss of consciousness or seizure.

If a user is unable to obtain unaffected strips, they should contact their health care provider for advice on how to treat these symptoms before they occur.

Details on hospital and user facility procedures and specific lot numbers can be accessed here. Customers can check if they have test strips from affected lots by visiting and looking up the product lot number.

Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ, and ReliOn Ultima customers can obtain information by calling Abbott Diabetes Care customer service at 1-800-448-5234 (English) or 1-800-709-7010 (Español).
The website and customer service phone numbers will also provide customers with information about returning affected test strips.

Unaffected Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strip lots may be used by customers to test blood glucose as directed by their health care providers.

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