Recall Z-2352-2021— Roche Diabetes Care, Inc.

Name: FDA recall Z-2352-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-28

Class II · Ongoing

Class II FDA medical device recall by Roche Diabetes Care, Inc., initiated 2021-07-28. It names one FDA 510(k) clearance: K133741. Product: Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001. Reason: 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..

Recalling firm: Roche Diabetes Care, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-07-28
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K133741 — ACCU-CHEK Performa Blood Glucose Monitoring SystemRoche Diagnostics·cleared 2014-08-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.