Abbott Glucose Test Strip Recall Classified as Class 1 Recall
The FDA has classified an Abbott glucose test strip recall as a Class 1 medical device recall, due to the risk that the test strips may provide inaccurate blood sugar readings and potentially cause diabetes patients to suffer a serious injury or even death.
The diabetes glucose test strip recall was originally announced on December 22, when Abbott sent a letter to customers notifying them of the problem. The Class 1 recall designation means that the FDA believes that these products pose a reasonable probability of causing serious injury or death.
The recall affects the Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, OptiumEZ and ReliON Ultima glucose test strips made by Abbott. The test strips were manufactured between January and September 2010, and are used with monitoring systems of the same names. The monitoring systems themselves are not being recalled.
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According to Abbott, the problem may be caused by longer than expected blood fill times and could also be affected by the age of the blood strip and how it was stored.
Abbott and the FDA recommend that customers using the affected strips discontinue using them and contact Abbott for free replacement strips. The Abbott letter contains detailed instructions on what to do if the customer has no access to unaffected strips.
Affected customers can receive more information by calling Abbott Diabetes Care customer service at 1-800-448-5234.
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