Z-3280-2018 Class II Terminated
FDA device recall Z-3280-2018 was initiated by Ortho-Clinical Diagnostics on May 5, 2018 and is designated Class II. Reason for recall: Potential for positively biased results The recall status is terminated (terminated Feb 19, 2021).
Recall Details
- Product Type
- Devices
- Report Date
- Oct 10, 2018
- Initiation Date
- May 5, 2018
- Termination Date
- Feb 19, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
VITROS Sodium Slides, Catalog # 837 9034
Reason for Recall
Potential for positively biased results
Distribution Pattern
US Nationwide, Bermuda, Austria, Brazil, Canada, Colombia, China, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium and the Netherlands
Code Information
UDI - 10758750004812 GENs- 8, 13, 14, 16, 17 & 18 Expiry Dates: 01-Nov-2018 through 01-Nov-2019
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3280-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026