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ADVIA® 120/2120/2120i 3-in-1 TESTpoint High Control 10318905Recalls & reported problems

Siemens Healthcare Diagnostics Inc. · ADVIA®120/2120/2120i 3-in-1 TESTpoint™ High Control · 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.

2 other recalls cover devices cleared under the same FDA submission (K993825); 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

  1. Jun 4, 2025Class IIOpen, Classified

    Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.

    Z-2089-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K993825. One submission often covers many models, so check the product and lot details in each record.

  • Z-2088-2025 · Jun 4, 2025 · Open, Classified
    ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
  • Z-2087-2025 · Jun 4, 2025 · Open, Classified
    ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)

Other CONTROL, CELL COUNTER, NORMAL AND ABNORMAL devices

All CONTROL, CELL COUNTER, NORMAL AND ABNORMAL devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page