Roche Diabetes Care, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2185-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 7, 2018

Date Posted: June 20, 2018

Recall Number: Z-2185-2018

Event ID: 80018

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.

Status: Terminated

Product Quantity: 295, 248

Code Information:

Lots 496947, 497291, 497296, 497325

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"

Voluntary or Mandated:

Voluntary: Firm initiated