C-SAA ANALYT MODULE ASSY 2120I 11314044Recalls & reported problems

Siemens Healthcare Diagnostics Inc. · ADVIA 2120i Refurbished System, Single Aspirate · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

19 other recalls cover devices cleared under the same FDA submission (K162977); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

Mar 5, 2021Class IIOpen, Classified
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Z-1392-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162977. One submission often covers many models, so check the product and lot details in each record.

Z-1403-2021 · Mar 5, 2021 · Open, Classified
ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Z-1397-2021 · Mar 5, 2021 · Open, Classified
ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Z-1391-2021 · Mar 5, 2021 · Open, Classified
ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Z-1396-2021 · Mar 5, 2021 · Open, Classified
ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Z-1386-2021 · Mar 5, 2021 · Open, Classified
ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Z-1399-2021 · Mar 5, 2021 · Open, Classified
ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Z-1388-2021 · Mar 5, 2021 · Open, Classified
ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, automated hematology analyzer -automated hematology analyzer Software Versions 6.10 and 6.11
Z-1405-2021 · Mar 5, 2021 · Open, Classified
ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Z-1400-2021 · Mar 5, 2021 · Open, Classified
ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Z-1390-2021 · Mar 5, 2021 · Open, Classified
ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Z-1393-2021 · Mar 5, 2021 · Open, Classified
ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Z-1387-2021 · Mar 5, 2021 · Open, Classified
ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, automated hematology analyzer -automated hematology analyzer Software Versions 6.10 and 6.11
Z-1404-2021 · Mar 5, 2021 · Open, Classified
ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Z-1395-2021 · Mar 5, 2021 · Open, Classified
ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Z-1389-2021 · Mar 5, 2021 · Open, Classified
ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer Software Versions 6.10 and 6.11

…and 4 more.

Device details

UDI-DI	`00630414237879`
Brand	C-SAA ANALYT MODULE ASSY 2120I
Model	11314044
Company	Siemens Healthcare Diagnostics Inc.
Product code	GKZ · Counter, differential cell
Class	Class 2
FDA submission	K162977
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 16, 2024

Device type (GMDN): Haematological cell analyser IVD

An electrically-powered automated or semi-automated laboratory instrument intended to be used for the enumeration of a haematological cell population, using technology which may include cell lysis, electrical impedance, conductivity, cytometry, and/or light scatter to measure and/or calculate white cell, red cell and platelet parameters and indices in a clinical specimen. Some types may also include measurement of haemoglobin.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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