Z-0599-2025 Class II Ongoing
FDA device recall Z-0599-2025 was initiated by Siemens Healthcare Diagnostics, Inc. on October 21, 2024 and is designated Class II. Reason for recall: Potential for falsely depressed auto-diluted results for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH ¿2-Microglobulin (B2M) reagent. The recall status is ongoing. Affected quantity: 11330 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 11, 2024
- Initiation Date
- October 21, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11330 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hungary, India, Iran, Israel, Italy, Ivory Coast, Japan, Jordan, Kuwait, Mexico, Morocco, Oman, P.R. China, Pakistan, Paraguay, Poland, Portugal, Saudi Arabia, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Switzerland, Thailand, Turkey, U.A.E., Uganda, United Kingdom, Uruguay, Uzbekistan, Vietnam, Zaire.