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Recall Observatory FDA recall evidence

Device 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

Z-1648-2022

July 18, 2022

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 90669
Status
Ongoing
Classification
Class II
Quantity
129 units US; 159 units OUS
Official record key
device-enforcement:Z-1648-2022

Official wording

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.

Code information: 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.

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Austria, France, ¿¿ Germany, Italy, Switzerland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.