Siemens Healthcare Diagnostics, Inc Recall 88792
Description: Atellica IM 1600 Analyzer, SMN 11066000
Siemens Healthcare Diagnostics, Inc Recall 88792 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0125-2022 |
| Event ID | 88792 |
| Event Description | Atellica IM 1600 Analyzer, SMN 11066000 |
| Product Type | Devices |
| Distribution | Domestic distribution to AZ CA CO GA ID KS MO MT NC NE NM NV OH OK OR PA TN TX UT VA WA WI WY. Foreign distribution worldwide. |
| Quantity | 1733 |
| Recall Reason | Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors. |
| Device Classification | 20211027 |
| Device Code Info | All units. |
| Center Classification Date | 20211016 |
| Recall Initiation Date | 20210928 |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc |
| Initial Notification | Letter |
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