Reported Sep 7, 2022 · Ongoing
Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3.…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 500 Gbc Dr · Newark, DE · 19702-2466
Is this the product you have?
- 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 Number10464344/K6456
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 Lot Numbers 2 lot 21340BB Exp Date: 2022-12-06 3 lot 22049BC (corrected 4 lot number 9/8/2022) Exp Date: 2023-02-18 5 lot 22112BF Exp Date: 2023-04-20. - Amount recalled
- 129 units US; 159 units OUS
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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