ADVIA Hematology System Control Product Recall for Platelet Value Error
Siemens Healthcare Diagnostics is recalling 3,266 units of ADVIA 120/2120/2120i 3-in-1 TESTpoint Control worldwide due to incorrect platelet value assignments that could affect test results.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device control product with a potential for incorrect test results affecting patient care, meeting the High severity threshold for risk-of-harm products where no reported illnesses are stated in the source.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control) due to incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems. The recall affects 3,266 units with Siemens Material Number 10318905 and UDI 00630414473413, specifically Lot Nos. TP253035 and TP253045.
The product has been distributed worldwide, including throughout the United States and internationally to 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.
The FDA classified this as a Class II recall. Affected healthcare facilities using these hematology systems should contact Siemens Healthcare Diagnostics for further instructions regarding the incorrect platelet value assignments and any necessary corrective actions.
The recalled product
- Product
- ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 3,266
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 10318905
- UDI: 00630414473413
- 00630414473413
- Lot No. TP253035
- TP253045.
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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