Siemens Healthcare Diagnostics, Inc. Recall 89740
Description: Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
Siemens Healthcare Diagnostics, Inc. Recall 89740 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0929-2022 |
| Event ID | 89740 |
| Event Description | Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536 |
| Product Type | Devices |
| Distribution | Global Distribution. US Nationwide. |
| Quantity | 6606 |
| 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: 00630414220505; Lot Numbers: 110027 110060 110065 110091 110113 110129 110137 110161 110170 110208 110224 110234 110235 110262 110265 110273 110286 110315 110330 110347 110360 |
| Center Classification Date | 20220414 |
| Recall Initiation Date | 20220209 |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc. |
| Initial Notification | Letter |
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