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Terminated

VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs

FDA Recall Z-0557-2014 · Posted 2013-12-20

Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeLOM
Date Initiated2013-10-25
Date Terminated2018-05-18
Product Quantity1,920 kits

Reason for Recall

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.

Firm 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 Technical Service representative at 1-800-421-3311.

Root Cause

Other

Distribution Pattern

Nationwide distribution - all states.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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