Z-1280-2024 Class II Ongoing
FDA device recall Z-1280-2024 was initiated by Siemens Healthcare Diagnostics, Inc. on Jan 24, 2024 and is designated Class II. Reason for recall: Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional… The recall status is ongoing. Affected quantity: 1,057 units (46 US, 1,011 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Mar 20, 2024
- Initiation Date
- Jan 24, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,057 units (46 US, 1,011 OUS)
Product Description
Reason for Recall
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AL, CA, IA, IL, MI, MN, NC, NE, NV, NY, OH and TX; The countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, India, Italy, Japan, Latvia, Malaysia, Netherlands, Norway, P.R. China, Pakistan, Poland, Portugal, Republic of South Korea, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, U.A.E., United Kingdom.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1280-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026