Device Recall AccuChek Aviva Plus Test Strip 의 리콜

Recall

80018

Class 2

Z-2186-2018

2018-05-07

2018-05-09

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164225

The recalling firm has identified two lots of test strips that are out of specification. affected test strips show an increased potential for: strip errors prior to applying a blood sample; strips not detected once inserted; or a biased result may occur, which may not be detectable. in the case of a biased result, incorrect action could be taken by the user in response to the displayed blood glucose result as compared to the actual blood glucose value.

"On May 7, 2018, the firm sent Urgent Medical Device Correction letters to affected Retailers, Suppliers, and Patients. Patients were instructed to check their test strip supply lot numbers against the recalled lots. Any test strips from the affected lots must be discarded. To get replacement test strips, patients should use one of the following options: o For fastest replacement of your product, please submit your request at https://notices.accu-chek.com o Email Accu-Chek Customer Care at accu-chek.care@roche.com and include the following information: your name, full mailing address, phone number, test strip lot number and number of affected test strip vials. o For questions regarding this recall, contact Accu-Chek Customer Care line at 1-800-358-4866 Monday through Friday between the hours of 8:00 am and 8:00 pm Eastern Standard Time. Suppliers were instructed to discontinue distribution and dispose of any remaining stock of the affected lots immediately. Suppliers were also asked to forward recall notifications to their customers, including both supplier- and consumer-level customers. Suppliers were asked to complete a faxback form indicating the total number of vials disposed of by the supplier and supplier customers. If you are a supplier and have questions about the information in this notification, please contact your Roche Account Manager. Retailers were instructed to discontinue sale or distribution and dispose of remaining affected lots in stock. Retailers were also asked to provide recall notification to their consumer customers. Retailers may note the quantity disposed and contact their Suppliers to arrange for credit. For questions please contact your wholesaler or the Accu-Chek Customer Care line at 1-800-358-4866 Monday through Friday between the hours of 8:00 am and 8:00 pm Eastern Standard Time. "