Siemens Healthcare Diagnostics, Inc. Recall 90872
Description: Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A
Siemens Healthcare Diagnostics, Inc. Recall 90872 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0089-2023 |
| Event ID | 90872 |
| Event Description | Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A |
| Product Type | Devices |
| Distribution | Nationwide Foreign: Canada |
| Quantity | 1592 units |
| Recall Reason | Dimension Vista¿ High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If an HDLC QC or patient result is obtained without an Abnormal Reaction [E145]: flag, a falsely depressed or elevated result ranging from -90% to 133% may be observed. |
| Device Classification | 20221026 |
| Device Code Info | UDI-DI : 0084276802043821250BA2022090710464340840 Lot Number: 21250BA Exp. Date: 2022-09-07 |
| Center Classification Date | 20221014 |
| Recall Initiation Date | 20220824 |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc. |
| Initial Notification | Letter |
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