# K162977: ADVIA 2120i, ADVIA 2120

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Aug 11, 2017 after 289 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 20 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K971998 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102644: Advia 2120 with Autoslide System, and Advia 2120I, Siemens Healthcare Diagnostics (2011) Summary page 4.

## Recalls of this device
- Mar 5, 2021 · Class II · Z-1390-2021: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- Mar 5, 2021 · Class II · Z-1395-2021: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- Mar 5, 2021 · Class II · Z-1393-2021: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- Mar 5, 2021 · Class II · Z-1404-2021: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- Mar 5, 2021 · Class II · Z-1400-2021: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- Mar 5, 2021 · Class II · Z-1403-2021: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- Mar 5, 2021 · Class II · Z-1394-2021: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- Mar 5, 2021 · Class II · Z-1396-2021: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- Mar 5, 2021 · Class II · Z-1386-2021: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- Mar 5, 2021 · Class II · Z-1399-2021: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- Mar 5, 2021 · Class II · Z-1402-2021: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- Mar 5, 2021 · Class II · Z-1398-2021: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- Mar 5, 2021 · Class II · Z-1392-2021: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- Mar 5, 2021 · Class II · Z-1397-2021: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- Mar 5, 2021 · Class II · Z-1387-2021: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- Mar 5, 2021 · Class II · Z-1388-2021: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- Mar 5, 2021 · Class II · Z-1401-2021: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- Mar 5, 2021 · Class II · Z-1389-2021: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- Mar 5, 2021 · Class II · Z-1391-2021: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- Mar 5, 2021 · Class II · Z-1405-2021: Potential Sample Identification (SID) Mismatch with14-Character Barcodes

## Indications for use
The ADVIA 2120 and ADVIA 2120i with auto slide are quantitative, automated hematology analyzers that provide the following information for in vitro diagnostic use in clinical laboratories: * A complete blood count (CBC) consisting of WBC, RBC, Hgb, CN-Free Hgb, Calculated Hgb, MCV, Het, MCH, MCHC, CHCM, RDW, HDW, CH, PIt, MPV. * A leukocyte differential count consisting of: Neut (%/#), Lymph (%/#), Mono (%/#), Eos (%/#) Baso (%/#), LUC (%/#). * A reticulocyte analysis consisting of Retic (%/#), MCVg, MCVr, CHCMg, CHCMr, CHg, CHr. » A nucleated red blood cell count consisting of NRBC (%/#). * Enumeration of the total nucleated cell (TNC) count and RBC count for pleural, peritoneal, and peritoneal dialysis (PD) specimens. Note: Above measurands are determined (in whole blood, pleural, peritoneal, or peritoneal dialysis specimens) with K2 and/or K3 EDTA anti-coagulants. * Quantitative determination of blood cells in Cerebrospinal Fluid (CSF) consisting of WBC, RBC, Neut (%/#), Lymph (%/#), Mono (%/#), MN (%/#), PMN (%/#). In addition, the system provides the added capability to automatically prepare and stain high quality blood smears on a glass microscope slide.

Source page: https://510kreport.com/device/K162977
Methodology: https://510kreport.com/methodology