Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001 Product Usage: The Accu-Chek Aviva Plus test strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.
Recall
- Recall Number
- Z-2185-2018
- Event Number
- 80018
- Firm
- Roche Diabetes Care, Inc.
- FEI Number
- 3011393376
- Product Code
- LFR
- Status
- Terminated
- Root Cause
- Equipment maintenance
- Initiated
- May 7, 2018
- Posted
- May 9, 2018
- Terminated
- January 16, 2020
- Address
- 9115 Hague Rd, Indianapolis, IN, 46256-1025
Description
Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001 Product Usage: The Accu-Chek Aviva Plus test strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.
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.
"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 [email protected] 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. "
Worldwide Distribution - US Nationwide distribution. Foreign distribution to Argentina Armenia Australia Austria Azerbaijan Bahamas Bahrain Barbados Belgium Brazil Bulgaria Canada Chile China Colombia Costa Rica Denmark Dominican Republic El Salvador Finland Georgia Germany Ghana Greece Guatemala Honduras Hong Kong (SAR China) Hungary India Indonesia Israel Italy Jamaica Japan Jordan Ireland Kenya Korea Kuwait Lebanon Lithuania Luxembourg Malaysia Malta Mexico Myanmar Netherlands New Zealand Norway Oman Pakistan Philippines Poland Russian Federation New Zealand Saudi Arabia Serbia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan (Republic of China), Thailand, United Arab Emirates, United Kingdom, Vietnam, Portugal"
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