Recall Z-1648-2022 · MOI System, Test, Immunological, Antigen, Tumor
Siemens Healthcare Diagnostics, Inc.
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
| Date | Aug 29, 2022 (initiated Jul 18, 2022) |
| Status | Open, Classified |
| 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. |
| 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 b |
| Quantity | 129 units US; 159 units OUS |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Austria, France, ¿¿ Germany, Italy, Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100344 | DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605 Siemens Healthcare Diagnostics, Apr 18, 2011 |