FDA Medical devices recall ·
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control) recall
- Recall number
- Z-2088-2025
- Date
- (initiated June 4, 2025)
- Company / brand
- Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave, Tarrytown, NY, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3,435 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
Why was it recalled?
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Siemens Material Number 10316217; UDI: 00630414473390, 00630414473390; Lot No. TP252035, TP252045.
Distribution
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.
States: Arkansas California Colorado Idaho Indiana
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2088-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.