FDAnews
www.fdanews.com/articles/166000-labeling-error-leads-to-recall-of-blood-glucose-test-strips

Labeling Error Leads to Recall of Blood Glucose Test Strips

July 23, 2014

Diabetic Supply of Suncoast is conducting a voluntary Class 1 nationwide recall of its Advocate Redi-Code+ BMB-BA006A blood glucose test strips due to a labeling error that omits the strips’ model number. The omission could lead to their use in the wrong glucose meter, resulting in incorrect results, the company says.

The Dorado, Puerto Rico, supply firm — which distributes the strips for Taiwan-based BroadMaster Bio-Tech — is recalling the strips to avoid confusion and possible misuse of the test strips with the Advocate Redi-Code blood glucose meter manufactured by Taidoc Technology, according to a recall notice posted to the FDA’s website on July 22.

Suncoast warned customers of the labeling lapse in early June, telling them to stop using the strips and contact the distributor for replacements. Wholesalers, pharmacies and healthcare providers should quarantine affected products and ensure the test strips are being used with the correct meter, the recall notice says. Suncoast will replace the strips with relabeled ones to avoid confusion.

Patients with falsely high or low glucose results may miss or delay treatments, which could lead to serious adverse health consequences, the company says.

The affected lots were distributed from January 2012 to June 6, 2014. View the recall notice at www.fdanews.com/ext/resources/files/07/07-23-14-StripRecall.pdf — Kellen Owings

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