Home / Recalls / Roche Diabetes Care, Inc. / Z-2185-2018

Z-2185-2018 Class II Terminated

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

FDA device recall Z-2185-2018 was initiated by Roche Diabetes Care, Inc. on May 7, 2018 and is designated Class II. 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… The recall status is terminated (terminated January 16, 2020). Affected quantity: 295, 248.

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 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.

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.

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

Lots 496947, 497291, 497296, 497325

Other recalls by Roche Diabetes Care, Inc.

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Z-1008-2022 Class II — RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. (March 9, 2022)
Z-2354-2021 Class II — Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05 (July 28, 2021)
Z-2352-2021 Class II — Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 072 (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-0751-2020 Class II — Blood Glucose Monitoring System, Model Number 08453063001 ACCU-CHEK GUIDE SAMPL (September 30, 2019)