Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,069

FDA device recall Z-2185-2018 · posted 2018-05-09 · Terminated

Recall details

Recalling firm

Roche Diabetes Care, Inc.

Reason for recall

The recalling firm identified four US lots of test strips out of specification. Affected strips show increased potential for strip errors prior to applying blood, strips not detected once inserted, or biased results, 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.

Action taken

"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. "

Root cause

Equipment maintenance

Status

Terminated

Product code

LFR

Quantity affected

295, 248

Distribution

Worldwide Distribution - US Nationwide distribution. Foreign distribution to Argentina Armenia Australia Austria Azerbaijan Bahamas Bahrain Barbados Belgium Brazil Bulgaria Canada Chile China Colombia

Date initiated

2018-05-07

Date posted

2018-05-09

Date terminated

2020-01-16

Location

Indianapolis, IN

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