Recall Z-1269-2023— Siemens Healthcare Diagnostics, Inc.
Class II · Ongoing
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2023-01-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097604. Reason: Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-01-27
- Firm location
- Tarrytown, NY, United States
Product description
Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097604
Reason for recall
Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results
Data sourced from openFDA. This site is unofficial and independent of the FDA.