ADVIA¿ 120/2120/2120i SETpoint Calibrator recall
ADVIA¿ 120/2120/2120i SETpoint Calibrator
Why was ADVIA¿ 120/2120/2120i SETpoint Calibrator 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 10312285; UDI: 00630414224343, 00630414224343; Lot No. SP251033, SP251043.
- Product
- ADVIA¿ 120/2120/2120i SETpoint Calibrator
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 2,020 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)