Siemens Healthcare Diagnostics, Inc. Recall 89740
Description: Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
Siemens Healthcare Diagnostics, Inc. Recall 89740 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0930-2022 |
| Event ID | 89740 |
| Event Description | Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637 |
| Product Type | Devices |
| Distribution | Global Distribution. US Nationwide. |
| Quantity | 199 |
| Recall Reason | Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results. |
| Device Classification | 20220420 |
| Device Code Info | UDI: 00630414595580; Lot Numbers: 211359 211451 |
| Center Classification Date | 20220414 |
| Recall Initiation Date | 20220209 |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc. |
| Initial Notification | Letter |
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