- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- The potential for falsely elevated results.
- Affected products (lot / model / serial)
- Siemens Material Number (SMN): 11537223; UDI-DI: 00630414610887; Lot numbers: All lots;
- Units affected
- 42940 units (3938 US, 39002 OUS)
- Distribution pattern
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Burkina Faso, Canada, Chile, China, Columbia, Croatia, Cura¿ao, St Eus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Jordan, Kenya, Korea, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, U.A.E., Uganda, United Kingdom , Uruguay, Uzbekistan, Vatikancity, Vietnam, Zaire.
- Firm location
- Tarrytown, NY, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3335-2026
- Recall initiated
- August 17, 2026
- FDA classification date
- September 30, 2026
- FDA report date
- October 7, 2026
- FDA event ID
- 99726
- Last updated on HTM Vibe
- October 13, 2026
