Z-1021-2022 Class II Ongoing
FDA device recall Z-1021-2022 was initiated by Siemens Healthcare Diagnostics, Inc. on Mar 3, 2022 and is designated Class II. Reason for recall: Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results The recall status is ongoing. Affected quantity: 374 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 11, 2022
- Initiation Date
- Mar 3, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 374 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, Bulgaria, Burkina, Faso Country AG, Cyprus, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Greece, Guadeloupe, India, Ireland, Israel, Italy, Kazakhstan, Latvia, Lithuania, Macedonia, Malta, Morocco, Nepal, Netherlands, Norway, Palestinian Ter, Paraguay, Poland, Portugal, Qatar, Romania, Russian Fed., Slovakia, Spain, Sweden, Switzerland, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Vatican city.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1021-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026