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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1648-2022
Event ID90669
Event DescriptionDimension 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 TypeDevices
DistributionWorldwide distribution - US Nationwide and the countries of Canada, Austria, France, ¿¿ Germany, Italy, Switzerland.
Quantity129 units US; 159 units OUS
Recall ReasonNegative 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 Classification20220907
Device Code InfoUDI: 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 Date20220829
Recall Initiation Date20220718
Recalling FirmSiemens Healthcare Diagnostics, Inc.
Initial Notification Letter
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