Z-3064-2024 Class II Ongoing
FDA device recall Z-3064-2024 was initiated by Siemens Healthcare Diagnostics, Inc. on Jul 29, 2024 and is designated Class II. Reason for recall: The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents. The recall status is ongoing. Affected quantity: 143 units (17 US, 126 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Sep 18, 2024
- Initiation Date
- Jul 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 143 units (17 US, 126 OUS)
Product Description
Reason for Recall
Distribution Pattern
Worldwide - US Nationwide distribution in the states of CA, FL, GA, IA, IL, KY, LA, MS, NJ, NY, NV, PA, TX, VA, PR and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Chile, China, Columbia, Croatia, Cura¿ao, St Eus, Czech Republic, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, India, Ireland, Italy, Jordan, Kenya, Korea, Kuwait, Latvia, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, U.A.E., United Kingdom, Uruguay, Vatikancity.
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-3064-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026