Z-1648-2022 Class II Ongoing
FDA device recall Z-1648-2022 was initiated by Siemens Healthcare Diagnostics, Inc. on Jul 18, 2022 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 129 units US; 159 units OUS.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 7, 2022
- Initiation Date
- Jul 18, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 129 units US; 159 units OUS
Product 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
Reason for Recall
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Austria, France, ¿¿ Germany, Italy, Switzerland.
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1648-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026