Hematology control material with incorrect platelet value assignments recalled
Siemens recalls a hematology quality control material due to incorrect platelet value assignments that could affect laboratory testing accuracy and result validation.
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 FDA Class II recall involves a quality control material with incorrect reference values. The hazard—inaccurate lab testing results from calibration errors—poses potential risk of harm, but no patient injuries or illnesses are mentioned in the recall notice, meeting the criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA® 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control), a quality control material used to verify the accuracy of hematology analyzers. A total of 4,214 units have been distributed worldwide.
The recalled products contain incorrect platelet (PLT) value assignments. This means the control material has reference values that do not match its actual platelet count, which could lead to incorrect calibration or quality control results in clinical laboratories.
The product was distributed worldwide, including throughout the United States and 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 affected units are identified by Siemens Material Number 10330063, UDI 00630414473406, and Lot Numbers TP251035 and TP251045.
Healthcare facilities and laboratories currently using this product should stop using the affected lots and contact Siemens Healthcare Diagnostics for guidance on replacements or corrective actions.
The recalled product
- Product
- ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- calibration-error
- incorrect-reference-values
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 10330063
- UDI: 00630414473406
- 00630414473406
- Lot No. TP251035
- TP251045.
Distribution
Distributed nationwide across the United States.
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