Recall Z-2186-2018 · LFR Glucose Dehydrogenase, Glucose

Roche Diabetes Care, Inc.

Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 Product Usage: The Accu-Chek Performa test strips are for use with the Accu-Chek Performa meter to quantitatively measure glucose (sugar) in venous whole blood or fresh capillary whole blood samples from the fingertips.

Date	May 9, 2018 (initiated May 7, 2018)
Status	Terminated
Reason	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.
Root cause	Equipment maintenance
Action	"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
Quantity	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 Costa Rica Denmark Dominican Republic El Salvador Finland Georgia Germany Ghana Greece Guatemala Ho
FDA record	Open on fda.gov

510(k) clearances named in this recall

K131029

ACCU-CHEK AVIVA PLUS TEST STRIP
Roche Diagnostics Operations, Inc., Aug 9, 2013