Siemens Healthcare Diagnostics, Inc. Recall 95116
Description: Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
Siemens Healthcare Diagnostics, Inc. Recall 95116 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-3065-2024 |
| Event ID | 95116 |
| Event Description | Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146; |
| Product Type | Devices |
| Distribution | Domestic: Nationwide Distribution. International: Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Qatar, Slovenia, Spain, Switzerland. |
| Quantity | 5,371 units (4,394 US, 977 OUS) |
| Recall Reason | During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) were processed on the Dimension Vista platform. There was an issue with the filling line which led to some wells to underfill in lot 23206BA. Calibrator, quality control (QC) and patient results could have been impacted. |
| Device Classification | 20240918 |
| Device Code Info | Siemens Material Number (SMN): 10445146; UDI-DI: 00842768015717; Lot Number: 23206BA; |
| Center Classification Date | 20240906 |
| Recall Initiation Date | 20240730 |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc. |
| Initial Notification | Letter |
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