ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
Summary
The FDA issued a Class II for ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control) by Siemens Healthcare Diagnostics, Inc.. Reason: Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems..
Details
Source
Device Recall
External ID
Z-2087-2025
Action Date
2025-07-09
Status
Ongoing
Category
device
Product Description
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
Lot/Code Info: Siemens Material Number 10330063; UDI: 00630414473406, 00630414473406; Lot No. TP251035, TP251045.
Quantity Affected: 4,214 units
Reason for Recall
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-04
Company
Tarrytown, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 153 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Siemens Healthcare Diagnostics, Inc. has 166 FDA actions in our database, including 142 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Healthcare Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Healthcare Diagnostics, Inc. have FDA actions?
Siemens Healthcare Diagnostics, Inc. has 166 FDA actions in our database, including 142 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2087-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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