Z-1648-2022Class II

Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of...

Name: Z-1648-2022 Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2022-07-18
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2022-07-18 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of 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... on 2022-07-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1648-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-18
Posted: 2022-08-29
Recalling firm: Siemens Healthcare Diagnostics Inc.
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
Product code: MOI System, Test, Immunological, Antigen, Tumor
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.
FDA root cause: Under Investigation by firm
Action: Siemens issued US Customers Urgent Medical Device Correction (VC-22-02.A.US) and OUS Customers Urgent Field Safety Notice (VC-22-02.A.OUS) dated July 2022 to inform them to use lot specific correlation factors with all in-date lots of Dimension Vista CA15-3. Letter states reason for recall, health risk and action to take: Calibrate/Recalibrate Dimension Vista LOCI CA 15-3 lots listed in Table 1 using any in date lot of Dimension Vista LOCI 7 Calibrator (SMN 10488446/ REF KC605). Enter lot specific correlation factors C0 and C1 in the Method Configuration screen per Flex reagent Lot listed below in Table 2. After applying correlation factors to the specified lot, product claims listed in the Instructions For Use (IFU) are met For instructions on entering correlation factors please refer to the Dimension Vista System Operator s Guide Rev A 2017-03 or online iGuide (Advanced Functions Section); Method Configuration, Section 9, page 9-25. Process Quality Control (QC) after recalibration and entry of lot specific correlation factors. The correlation factors may create an upward QC shift. Please follow your current laboratory process for adjusting QC ranges. Siemens is providing some examples of CA15-3 lot specific QC values calculated for the three in-date lots of Dimension Vista LOCI CA15-3. CA 15-3 lot specific bottle values for representative sets of QC materials are shown in Table 3. Correlation Factors will remain in the LOCI CA 15-3 Method configuration until removed manually or revised by the user. You may receive future shipments of lots listed in Table 1. Be sure to retain this letter in order to apply correlation factors to CA15-3 lots listed in Table 1. Subsequent lots may require correlation factors. An Alert Card will be included in the subsequent lots with the lot specific correlation factors and lot specific QC. Please review this letter with your Medical Director. If you have any questions, please contact your Siemens Healthineers Customer
Quantity in commerce: 129 units US; 159 units OUS
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Austria, France, ¿¿ Germany, Italy, Switzerland.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1648-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1648-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-07	2022-08-29

Product code MOI

K100344Class IIDimension Vista Loci Ca 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7 Calibrator, Models: K6456 and Kc605Siemens Healthcare Diagnostics / cleared 2011-04-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)