Z-1268-2023 Class II Ongoing
FDA device recall Z-1268-2023 was initiated by Siemens Healthcare Diagnostics, Inc. on January 27, 2023 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 8420 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 6, 2023
- Initiation Date
- January 27, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8420 units
Product Description
Reason for Recall
Distribution Pattern
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