Z-0493-2026 Class II Ongoing
FDA device recall Z-0493-2026 was initiated by Siemens Healthcare Diagnostics, Inc. on October 6, 2025 and is designated Class II. Reason for recall: The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a … The recall status is ongoing. Affected quantity: 28 units (OUS only).
Recall Details
- Product Type
- Devices
- Report Date
- November 19, 2025
- Initiation Date
- October 6, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28 units (OUS only)
Product Description
Reason for Recall
Distribution Pattern
Worldwide - US Nationwide distribution in the state of CA and the countries of Argentina, Australia, Austria, Belgium, Bosnia Herzeg. , Brazil, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Estonia, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Israel, Italy, Latvia, Macedonia, Mexico, Netherlands, Norway, Pakistan, Panama, Poland, Portugal, Romania, Russian Fed., Serbia, Slovakia, Spain, Sweden, Turkey, U.A.E., Ukraine, United Kingdom, Uruguay.