Medical device control material has incorrect platelet value assignments
Siemens is recalling a diagnostic control product used with laboratory hematology systems. The control material has incorrect platelet value assignments.
What this means for you
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 medical device recall of a diagnostic control product with incorrect measurement values, presenting a risk to diagnostic accuracy. No illnesses, injuries, or deaths have been reported; however, the defect could affect laboratory results that inform patient care decisions.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control) diagnostic control material. The control has incorrect platelet (PLT) value assignments for use with ADVIA 120/2120/2120i hematology systems.
Because the control material contains incorrect values, it could provide inaccurate reference data when used to verify or calibrate ADVIA hematology systems. This could affect laboratory results.
The affected control material was distributed worldwide, including throughout the United States and to 24 countries. Approximately 3,435 units are affected. The material is identified by Siemens Material Number 10316217 and lot numbers TP252035 and TP252045.
Laboratories using this control material should contact Siemens Healthcare Diagnostics immediately. Facilities should discontinue use of this product and arrange for replacement or alternative control material.
The recalled product
- Product
- ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- measurement-error
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
Distributed nationwide across the United States.
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