Z-0366-2026 Class II Ongoing
FDA device recall Z-0366-2026 was initiated by Siemens Healthcare Diagnostics, Inc. on September 22, 2025 and is designated Class II. Reason for recall: The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified… The recall status is ongoing. Affected quantity: 3318 units (169 US, 3149 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- November 5, 2025
- Initiation Date
- September 22, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3318 units (169 US, 3149 OUS)
Product Description
Reason for Recall
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AL, CA, DC, FL, ID, IN, LA, MD, NC, NJ, NY, PA, SC and the countries of Argentina, Australia, Bolivia, Bosnia Herzeg, Brazil, Bulgaria, Canada, Chile, Colombia, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, Hungary, India, Iran, Israel, Italy, Kosovo, Kuwait, Latvia, Lebanon, Macedonia, Mexico, Nepal, Netherlands, P.R. China, Pakistan, Palestinian Ter, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovakia, Slovenia, South Africa, Spain, Taiwan, Tunisia, Turkey, Turkmenistan, U.A.E., Ukraine, Uruguay, Uzbekistan.