CLASS II ONGOING Device recall · Reported 9 Jul 2025 · FDA Enforcement Report
Advia¿ 120/2120/2120i-1 TESTpoint Control (ABN1 Control) recalled
Siemens Healthcare Diagnostics is recalling Advia¿ 120/2120/2120i-1 TESTpoint Control (ABN1 Control), distributed nationwide in the US. The recall was initiated on 4 Jun 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2087-2025
- FDA event ID
- 97037
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Jun 2025
- FDA classified
- 3 Jul 2025
- Reported
- 9 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 4 Jun 2025 | Recall initiated by company | |
| 3 Jul 2025 | Classified by FDA | +29 days |
| 9 Jul 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
Product as listed by the FDA
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
Where it was distributed
Worldwide distribution - US Nationwide and the countries of AR, AU, BR, CA, CL, CN, CO, CR, HK, ID, IN, JP, KR, MX, MY, PE, PY, SA, SG, TH, TW, UY, VN, & ZA.
Questions about this recall
Why was it recalled?
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
Which lots are affected?
Siemens Material Number 10330063; UDI: 00630414473406, 00630414473406; Lot No. TP251035, TP251045.
Where was it sold?
Worldwide distribution - US Nationwide and the countries of AR, AU, BR, CA, CL, CN, CO, CR, HK, ID, IN, JP, KR, MX, MY, PE, PY, SA, SG, TH, TW, UY, VN, & ZA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 97037This product is part of a recall event; the main page for the event is Advia¿ 120/2120/2120i-1 TESTpoint Control (ABN2 Control) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Advia¿ 120/2120/2120i-1 TESTpoint Control (ABN2 Control) recalled | Siemens Healthcare Diagnostics | Other | Nationwide | |
| CLASS II | Advia¿ 120/2120/2120i-1 TESTpoint Control (Norm Control) recalled | Siemens Healthcare Diagnostics | Other | Nationwide | |
| CLASS II | Advia¿ 120/2120/2120i SETpoint Calibrator recalled | Siemens Healthcare Diagnostics | Other | Nationwide |
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