Siemens Healthcare Diagnostics, Inc. Recall 90669
Description: Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456
Siemens Healthcare Diagnostics, Inc. Recall 90669 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1648-2022 |
| Event ID | 90669 |
| Event Description | Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Austria, France, ¿¿ Germany, Italy, Switzerland. |
| Quantity | 129 units US; 159 units OUS |
| Recall Reason | Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisions. |
| Device Classification | 20220907 |
| Device Code Info | UDI: 0084276802852621340BB22120610464344840, 0084276802852622049BC23021810464344840, 0084276802852622112BF23042210464344840. Lot Numbers: lot 21340BB Exp Date: 2022-12-06; lot 22049BC (corrected lot number 9/8/2022) Exp Date: 2023-02-18; lot 22112BF Exp Date: 2023-04-20. |
| Center Classification Date | 20220829 |
| Recall Initiation Date | 20220718 |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc. |
| Initial Notification | Letter |
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