8/6/2023 0 Comments Accu chek inform ii testThe intended use statements found in the package inserts or manuals of many such products do not include the monitoring of glycemic control for non-diabetic patients in hospitals, or use on critically ill patients.Īs clarified in a frequently asked questions document issued on February 18, the purpose of the Department of Health’s letter was to “inform facilities on the policies and requirements surrounding off-label use of these devices.” Specifically, laboratories that use glucose meters for purposes or populations beyond the approved intended use are considered to be engaging in off-label use. In the past, however, manufacturers’ validation data has not been sufficient for FDA to extend this approved intended use to other patient populations or settings. The department’s letter followed by just a few days the issuance of two FDA guidance documents in which the agency established new premarket submission requirements for blood glucose monitors.įDA has long approved glucose meters for the measurement of whole blood glucose, and for use by healthcare professionals as an aid in monitoring the effectiveness of a diabetes control program. This record will be updated as the status changes.On January 13, 2014, the New York State Department of Health sent to its licensed New York laboratories a “Dear Laboratory Director” letter regarding off-label use of glucose meters. Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ The manufacturer has initiated the recall and not all products have been corrected or removed. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Worldwide distribution - US Nationwide distribution.ġ A record in this database is created when a firm initiates a correction or removal action. Urgent Medical Device Correction(UMDC) by phone at 1-80 or on our website at under Contact Us for email or chat. Dispose of the affected test strips and vial according to your local guidelines.Ĭontact Accu-Chek Customer Care if you have questions regarding the information in this Complete and return the business reply letter to the recalling firm.ĥ. On our website at under Contact Us for email or chat. 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 System, test, blood glucose, over the counter - Product Code NBWĪccu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001 Class 2 Device Recall AccuChek Inform II Test Strip
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