Siemens Healthcare Diagnostics, Inc. is recalling 12,935 units of ADVIA 120/2120/2120i SETpoint Calibrators and 3-in-1 TESTpoint Controls. The recalled products were found to have incorrect platelet (PLT) value assignments, which are used to calibrate and monitor the accuracy of ADVIA 120, 2120, and 2120i Hematology Systems. These systems are used in clinical laboratories to analyze blood samples. Using these calibrators or controls with incorrect values could lead to the instrument reporting inaccurate patient results.
Incorrect platelet calibration values can cause hematology systems to report patient platelet levels that are either higher or lower than they actually are. This defect could lead to medical providers making incorrect diagnoses or prescribing inappropriate treatments based on flawed laboratory data.
Siemens Material Number 10312285
Siemens Material Number 10330063
Siemens Material Number 10316217
Siemens Material Number 10318905
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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