Z-1253-2022 Class II Ongoing
FDA device recall Z-1253-2022 was initiated by Siemens Healthcare Diagnostics, Inc. on Apr 13, 2022 and is designated Class II. Reason for recall: Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results The recall status is ongoing. Affected quantity: 2,321.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 15, 2022
- Initiation Date
- Apr 13, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,321
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Albania, Argentina, Austria, Bahamas, Bangladesh, Belgium, Brazil, Chile, China, Columbia, Croatia, Czech¿Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, India, Israel, Italy, Japan, Korea, Latvia, Malaysia, Mexico, Netherlands, Paraguay, Peru, Philippines, Portugal, Romania, Russian¿Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., United Kingdom, Vietnam.
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-1253-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026