FDA recall Z-2354-2021

Product

Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001

Reason for recall

Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.

Distribution

Worldwide distribution - US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2021-07-28

Report date

2021-09-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2354-2021