Roche Diabetes Care, Inc. Recall 88362
Description: Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001
Roche Diabetes Care, Inc. Recall 88362 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2351-2021 |
| Event ID | 88362 |
| Event Description | Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution. |
| Quantity | 10,546,420 (US), 19,120,668 (OUS) |
| Recall 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. |
| Device Classification | 20210901 |
| Device Code Info | Since this is a labeling correction, this recall is not lot specific and is applicable to all non-expired lots. |
| Center Classification Date | 20210826 |
| Recall Initiation Date | 20210728 |
| Recalling Firm | Roche Diabetes Care, Inc. |
| Initial Notification | Letter |
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