—#195370

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

FDA product code: MOI — System, Test, Immunological, Antigen, Tumor
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K100344
Affected lot / code info: 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.

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr, Newark, Delaware 19702-2466

Distribution

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

Timeline

Recall initiated: 2022-07-18
Posted by FDA: 2022-08-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #195370. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.