Z-0465-2019 Class II Terminated
FDA device recall Z-0465-2019 was initiated by Siemens Healthcare Diagnostics, Inc. on Sep 7, 2018 and is designated Class II. Reason for recall: There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots. The recall status is terminated (terminated Nov 16, 2020). Affected quantity: 18396.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 21, 2018
- Initiation Date
- Sep 7, 2018
- Termination Date
- Nov 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18396
Product Description
Reason for Recall
Distribution Pattern
Worldwide - US Nationwide Distributions The products were distributed to the following foreign countries: Argentina, Australia, Bangladesh, Brazil, Canada, Chile, China, Colombia, Germany, Ecuador, Honduras, Indonesia, India, Japan, Republic of Korea, Mexico, Malaysia, Nicaragua, New Zealand, Peru, Philippines, Paraguay, El Salvador, Thailand, Taiwan, Uruguay and South Africa, Austria, Bahamas, Belgium, Czech Republic, Denmark, , France, , Italy, Netherland, Norway , Portugal, Kuwait, Slovenia, Spain, Switzerland, United Kingdom, Qatar, Republic of Korea, Saudi Arabia, Slovakia, Algeria, Bahrain, Bulgaria, Egypt, , Hungary, Latvia, Lebanon, Lithuania, Macedonia, Nepal, Poland, Romania, Russia Fed, Serbia, Turkey, U.A.E, United Kingdom.
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-0465-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026