Contact Accu-Chek Customer Care for product replacement if you open a sealed carton and any of the vials inside meet the criteria listed above by phone at 1-80 or
DO NOT perform control testing if you open a sealed carton and ay of the vials inside meet the criteria listed above.ģ. Anything prevents the cap from closing properlyĢ. You see any damage to the cap or vial, or The vial is open or damaged before using the test strips for the first time Check vials of affected test strips before use. Inappropriate therapy decisions based on inaccurate results could lead to adverse health consequences.ġ. Customers were warned that open vials may expose the test strips to humidity, which might damage the strips and result in inaccurate results (such as positively biased or falsely too high results). On July 28, 2021, the firm issued an Urgent Medical Device Correction to affected customers regarding the potential for open vials. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences. Test strip vials may open while inside sealed cartons during shipment. Since this is a labeling correction, this recall is not lot specific and is Class 2 Device Recall AccuChek Aviva Plus Test Strip
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