Tuesday, December 28, 2010

Recall Notice: Abbott Glucose Test Strips: Recall - False Low Blood Glucose Results

Recall Notice: Abbott Glucose Test Strips: Recall - False Low Blood Glucose Results
(including Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, OptiumEZ, ReliOn Ultima)

On December 22, 2010, The FDA and Abbott Diabetes Care issued a recall notification to healthcare professionals and patients regarding the recall of 359 different lots of glucose test strips marketed under the following brand names: Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, OptiumEZ and ReliOn Ultima. The issue relates to the insufficient absorption of blood into the test strip. Test strips included in the recall may give falsely low blood glucose results, which can lead patients to try to raise their blood glucose when it is unnecessary, or to fail to treat elevated blood glucose due to a falsely low reading. The recalled test strips are used with Abbott’s Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, Optium EZ and ReliOn Ultima blood glucose monitoring systems. As many as 359 million strips may be affected by the recall. The test strips, which were manufactured between January and May 2010, are sold both in retail and online settings directly to consumers, but are also used in health care facilities. Patients with diabetes should be aware of this problem and take steps to prevent it from affecting their health. Customers can check if they have tests trips from the recalled lots by visiting Abbott’s website to look up their product lot number: www.precisionoptiuminfo.com. Click here for more information.

Wednesday, December 1, 2010

Recall Notice: B. Braun addEASE Binary Connector: Class I Recall -Stopper Fragments May Enter Bag

On November 30, 2010, B Braun Medical Inc. issued a reiteration of a prior June 28, 2010 recall on use of its addEASE Binary Connectors. The organization identified that when an addEASE Binary Connector is inserted into a partial additive bag (PAB) stopper, fragments of the stopper may enter the bag, resulting in a small amount of visible particles in the solution. These particles can potentially enter a patient’s body and lead to serious injury and/or death. It is recommended that anyone currently using this product discontinue doing so immediately. Click here for more information.