FDA Device recall Z-2354-2021
Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001
- FDA Device
- Class II
- ongoing
- Published 2021-09-01
On 2021-09-01 the FDA classified a Class II recall of Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001 by Roche Diabetes Care, citing 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 inaccurat….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2354-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-07-28 |
| Published | 2021-09-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roche Diabetes Care |
| Distribution | US |
Product
Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001
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.
Identifiers
| code_info | Since this is a labeling correction, this recall is not lot specific and is applicable to all non-expired lots. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2354-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.