Roche Diabetes Care, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2353-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001

Product Classification:

Class II

Date Initiated: July 28, 2021

Date Posted: September 1, 2021

Recall Number: Z-2353-2021

Event ID: 88362

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.

Status: Ongoing

Product Quantity: 1,150,755 (US)

Code Information:

Since this is a labeling correction, this recall is not lot specific and is applicable to all non-expired lots.

Distribution Pattern:

Worldwide distribution - US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated