Recall Z-0557-2014 ยท LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Ortho-Clinical Diagnostics
VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
| Date | Dec 20, 2013 (initiated Oct 25, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | On October 25, 2013, Ortho Clinical Diagnostics issued product correction notifications to their US customers via US Postal Service Priority Mail and email notices to their foreign affiliates informing them of the recall. Ortho Clinical Diagnostics advised their customers to review previously reported results between > 12 and <30 mIU/mL and consult the Laboratory Medical Director. Customers were instructed to utilize alternative methods for anti-HBs testing. Customers are advised to seek alternative methods for anti-HBs testing. For additional information, please contact the OCD Customer |
| Quantity | 1,920 kits |
| Distribution | Nationwide distribution - all states. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.