Siemens Healthcare Diagnostics, Inc. Recall 91665
Description: Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma (lithium heparin, potassium EDTA) using the Atellica CH Analyzer SMN: 11097591
Siemens Healthcare Diagnostics, Inc. Recall 91665 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1270-2023 |
| Event ID | 91665 |
| Event Description | Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma (lithium heparin, potassium EDTA) using the Atellica CH Analyzer SMN: 11097591 |
| Product Type | Devices |
| Distribution | Nationwide Foreign: Country Albania Algeria Argentina Australia Austria Bahrain Bangladesh Belgium Brazil Bulgaria Burkina Faso Canada Chile China Colombia Croatia Cura¿ao Czech Republic Denmark Ecuador Egypt Finland France Germany Greece Guadeloupe Hong Kong Hungary India Ireland Israel Italy Japan Kuwait Libya Malaysia Mexico Netherlands New Zealand Norway Oman Pakistan Paraguay Peru Philippines Poland Portugal Qatar Republic Korea Romania Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan, Province of China Thailand Ukraine United Arab Emirates United Kingdom Great Britain Uruguay Vatikancity Vietnam |
| Quantity | 11824 units |
| Recall Reason | Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results |
| Device Classification | 20230906 |
| Device Code Info | UDI: 00630414596495 All Lots |
| Center Classification Date | 20230829 |
| Recall Initiation Date | 20230127 |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc. |
| Initial Notification | Letter |
| Similar To |