Home / Recalls / Roche Diabetes Care, Inc. / Z-2186-2018

Z-2186-2018 Class II Terminated

Recalled by Roche Diabetes Care, Inc. — Indianapolis, IN

Recall Details

Product Type
Devices
Report Date
June 20, 2018
Initiation Date
May 7, 2018
Termination Date
January 16, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
295,248

Product Description

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.

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.

Distribution Pattern

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"

Code Information

Lot 476605

Other recalls by Roche Diabetes Care, Inc.

  • Z-2174-2024 Class II — Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh ca (May 13, 2024)
  • Z-1008-2022 Class II — RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. (March 9, 2022)
  • Z-2352-2021 Class II — Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 072 (July 28, 2021)
  • Z-2354-2021 Class II — Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05 (July 28, 2021)
  • Z-2353-2021 Class II — Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: (July 28, 2021)
  • Z-2351-2021 Class II — Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: (July 28, 2021)
  • Z-0998-2020 Class II — Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring (December 11, 2019)
  • Z-0997-2020 Class II — Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitori (December 11, 2019)
  • Z-0999-2020 Class II — ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System (December 11, 2019)
  • Z-0752-2020 Class II — Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HCP S (September 30, 2019)