Z-1674-2021 Class II Ongoing
FDA device recall Z-1674-2021 was initiated by Siemens Healthcare Diagnostics, Inc on April 21, 2021 and is designated Class II. Reason for recall: Potential for the ADVIA Centaur Syphilis assay to carryover into other commercial assays. This carryover effect only occurs when the impacted assays are used immediately following testing with the Syp… The recall status is ongoing. Affected quantity: 22550 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 2, 2021
- Initiation Date
- April 21, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22550 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Austria, Belgium, Burkina Faso, Croatia, Czech Republic, Egypt, Finland, France, Fren.Polynesia, Georgia, Germany, Germany, Greece, Guadeloupe, Italy, Kazakhstan, Latvia, Netherlands, Norway, Poland, Portugal, Qatar, Russian Fed., Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, U.A.E., Ukraine, United Kingdom.