ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control recall
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
Why was ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control recalled?
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Siemens Material Number 10330063; UDI: 00630414473406, 00630414473406; Lot No. TP251035, TP251045.
- Product
- ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 4,214 units
- 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.
- Recall date
- July 9, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)