FDA Device recall Z-1648-2022
Dimension Vista LOCI CA 15-3 Flex reagent cartridge
- FDA Device
- Class II
- ongoing
- Published 2022-09-07
On 2022-09-07 the FDA classified a Class II recall of Dimension Vista LOCI CA 15-3 Flex reagent cartridge by Siemens Healthcare Diagnostics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1648-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-07-18 |
| Published | 2022-09-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | UDI: 0084276802852621340BB22120610464344840, 0084276802852622049BC23021810464344840, 0084276802852622112BF23042210…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1648-2022%22
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