Siemens Healthcare Diagnostics, Inc. Recall 90900
Description: Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
Siemens Healthcare Diagnostics, Inc. Recall 90900 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0105-2023 |
| Event ID | 90900 |
| Event Description | Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide. |
| Quantity | 586 US; 694 OUS |
| Recall Reason | Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium patient results, which may lead to inappropriate dosage adjustment, potentially affecting treatment efficacy. |
| Device Classification | 20221026 |
| Device Code Info | UDI-DI: 00630414006789 All lots impacted: Lots 110354 exp 11/15/22 120038 exp 2/7/23 |
| Center Classification Date | 20221020 |
| Recall Initiation Date | 20220919 |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc. |
| Initial Notification | Letter |
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