ADVIA Hematology Control Recalled for Incorrect Platelet Value Assignments
Siemens Healthcare Diagnostics is recalling ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control) units because they have incorrect platelet value assignments for the hematology systems.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. No illnesses, injuries, or deaths are reported in the source text. The hazard is a quality/accuracy defect in a control material (not the diagnostic system itself), with no evidence of patient harm documented.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 3,435 units of ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control) hematology analyzer controls. The products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
The affected controls were distributed worldwide, including the United States and 24 other countries (Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Hong Kong, Indonesia, India, Japan, South Korea, Mexico, Malaysia, Peru, Paraguay, Saudi Arabia, Singapore, Thailand, Taiwan, Uruguay, Vietnam, and South Africa).
Healthcare facilities using these controls should quarantine the affected lots (TP252035 and TP252045) and contact Siemens Healthcare Diagnostics for replacement or further instructions. The Siemens Material Number is 10316217, and the UDI is 00630414473390.
The recalled product
- Product
- ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 3,435
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Siemens Material Number 10316217
- UDI: 00630414473390
- 00630414473390
- Lot No. TP252035
- TP252045.
Distribution
Part of a larger recall action
This product is one of 4 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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