FDAFDA · Food and drugs·Recall number Z-3280-2018
VITROS Sodium Slides, Catalog # 837 9034
Published October 10, 2018 · Recall initiated: May 5, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for positively biased results
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ortho-Clinical Diagnostics
- Distributor
- 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
- Lot
- UDI - 10758750004812 GENs- 8, 13, 14, 16, 17 & 18 Expiry Dates: 01-Nov-2018 through 01-Nov-2019
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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