ADVIA Hematology Analyzer Control Has Incorrect Platelet Values
Siemens is recalling ADVIA hematology analyzer control products due to incorrect platelet (PLT) value assignments. Approximately 3,266 units are affected, with lot numbers TP253035 and TP253045.
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 a Class II medical device recall involving a risk of harm through inaccurate laboratory control values. No illnesses or injuries have been reported. Per the FDA severity rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Siemens Healthcare Diagnostics is recalling the ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control) because the product contains incorrect platelet (PLT) value assignments. The product is a control material used with ADVIA 120/2120/2120i Hematology Systems to verify analyzer performance.
A total of 3,266 units have been distributed worldwide, including throughout the United States and 23 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). The affected lot numbers are TP253035 and TP253045. The Siemens Material Number is 10318905, and the UDI is 00630414473413.
Control materials with incorrect value assignments may not provide accurate reference values for verifying instrument performance. Healthcare facilities using ADVIA systems should identify any stock of the affected lots and contact Siemens Healthcare Diagnostics for instructions regarding replacement control materials.
The recalled product
- Product
- ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- incorrect-control-values
- diagnostic-error-risk
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
Distributed nationwide across the United States.
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