FDAFDA · Food and drugs·Recall number Z-0557-2014
VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
Published January 1, 2014 · Recall initiated: October 25, 2013
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
Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products Anti-HBs Calibrators and Anti-HBs Quantitative Reagent Packs due to false positive results.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ortho-Clinical Diagnostics
- Distributor
- Nationwide distribution - all states.
- Lot
- Product Code 1) 6801926, 2) 6801925, 3) 6802452 Lot numbers: 1) 6700, 2) 6731, 3) 6830 Expiry Dates: 1) 21 May 2013, 2) 24 July 2013, 3) 11 Sept 2013
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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