—#124095

Product

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

FDA product code: LOM — Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Device class: Class 2
Medical specialty: Microbiology
PMA numbers: P000014, P000014S025
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Dr, Rochester, New York 14626-5101

Distribution

Distribution pattern: Nationwide distribution - all states.

Timeline

Recall initiated: 2013-10-25
Posted by FDA: 2013-12-20
Terminated: 2018-05-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124095. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.