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

FDA device recall Z-0557-2014 · posted 2013-12-20 · Terminated

Recall details

Recalling firm

Ortho-Clinical Diagnostics

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.

Action taken

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

Status

Terminated

Product code

LOM

Quantity affected

1,920 kits

Distribution

Nationwide distribution - all states.

Date initiated

2013-10-25

Date posted

2013-12-20

Date terminated

2018-05-18

Location

Rochester, NY