Z-1685-2025 Class II Ongoing
FDA device recall Z-1685-2025 was initiated by Siemens Healthcare Diagnostics Inc on March 19, 2025 and is designated Class II. Reason for recall: The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n. The recall status is ongoing. Affected quantity: 5,207 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 7, 2025
- Initiation Date
- March 19, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,207 units
Product Description
Reason for Recall
Distribution Pattern
Domestic: Nationwide Distribution; Foreign: Albania, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia, Brazil, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Ecuador, Estonia, France, Germany, Ghana, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Lithuania, Malaysia, Mali, Martinique, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nigeria, Oman, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Vietnam.