Recall Z-2187-2018— Roche Diabetes Care, Inc.

Name: FDA recall Z-2187-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-07

Class II · Terminated

Class II FDA medical device recall by Roche Diabetes Care, Inc., initiated 2018-05-07, terminated 2020-01-16. It names one FDA 510(k) clearance: K131029. Product: Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 Product Usage: The Accu-Chek Inform II test strips are for use with the Accu-Chek Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heel stick, or fresh capillary whole blood samples drawn from the fingertips as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples.. 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..

Recalling firm: Roche Diabetes Care, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-05-07
Terminated: 2020-01-16
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K131029 — ACCU-CHEK AVIVA PLUS TEST STRIPRoche Diagnostics Operations, Inc.·cleared 2013-08-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 Product Usage: The Accu-Chek Inform II test strips are for use with the Accu-Chek Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heel stick, or fresh capillary whole blood samples drawn from the fingertips as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.