Z-2542-2025 Class II Ongoing
FDA device recall Z-2542-2025 was initiated by Siemens Healthcare Diagnostics, Inc. on August 11, 2025 and is designated Class II. Reason for recall: Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results. The recall status is ongoing. Affected quantity: 11,811 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 17, 2025
- Initiation Date
- August 11, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,811 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Denmark, Egypt, Estonia, Ethiopia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Macedonia, Malaysia, Maldives, Mexico, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, U.A.E., United¿Kingdom, Uruguay, Vatikancity, Vietnam, Zaire.