Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II… — Class II medical device recall Z-1172-2016
Terminated recall by Roche Diagnostics Operations, Inc., reported 2016-03-23, distributed nationwide. Accu-Chek Inform II Base Unit might produce physical transmission errors in the form of data loss in the commu
| Recall number | Z-1172-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2016-02-11 |
| Classified | 2016-03-14 |
| Reported by FDA | 2016-03-23 |
| Terminated | 2017-05-30 |
| Distributed | Nationwide (US) |
| Serial numbers | UU41000000 |
| Model numbers | 05060290001 |
Product
Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System Accu-Chek inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings. This system should only be use with single-use, auto-disabling lancing devices.
Reason for recall
Accu-Chek Inform II Base Unit might produce physical transmission errors in the form of data loss in the communication between the meter and the Data Management Systems (DMS). The issue can lead to the data loss or in the worst case to an erroneous assignment of the patient data (patient mismatch). The issue will only occur at sites using POTCT1-A communication via USB.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1172-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.