Recall Z-2354-2021 ยท NBW System, Test, Blood Glucose, Over The Counter
Roche Diabetes Care, Inc.
Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001
| Date | Jul 28, 2021 |
| Status | Open, Classified |
| 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. |
| Root cause | Package design/selection |
| Action | On July 28, 2021, the firm issued an Urgent Medical Device Correction to affected customers regarding the potential for open vials. Customers were warned that open vials may expose the test strips to humidity, which might damage the strips and result in inaccurate results (such as positively biased or falsely too high results). Inappropriate therapy decisions based on inaccurate results could lead to adverse health consequences. ACTIONS REQUIRED BY USERS: 1. Check vials of affected test strips before use. DO NOT use test strips if: - The vial is open or damaged before using the test strips |
| Quantity | 9,555,555 (US); 5,128,758 (OUS) |
| Distribution | Worldwide distribution - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121679 | ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM Roche Diagnostics, Oct 11, 2012 |