—#43314

Product

Vitros Immunodiagnostic HBsAg CONFIRMATORY KIT * REF 680 1324. Firm on label: Ortho-Clinical Diagnostics, 62 The Broadway, Amersham, Bucks, UK. UPC *+H221680132412* . Each kit contains: 1 x kit of reagents, and protocol card for HBsAg Confirmatory Kit. According to the firm (but not on label), there are 60 neutralization reactions per confirmatory kit.

FDA product code: LOM — Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Device class: Class 2
Medical specialty: Microbiology
Affected lot / code info: Lot 5140, exp. 4/13/2006; Lot 5150, exp. 5/31/2006; and Lot 5160, exp. 7/3/2006

Why it was recalled

Increased background signal of the sample diluent in the affected Confirmatory Kits could cause some results to be classified as 'Not Confirmed'.

Root cause (FDA determination)

Other

Action the firm took

Letters sent overnight mail on 12/15/2005. Customers instructed to discontinue use and discard remaining inventory. In a separate Q&A sheet, Ortho recommends that previously reported results be reviewed.

Recalling firm

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

Distribution

Distribution pattern: Nationwide distribution to end users (medical facilities, testing labs and public health agencies). One J&J foreign affiliate in Puerto Rico with sub-distribution in the Caribbean.

Timeline

Recall initiated: 2005-12-15
Posted by FDA: 2006-01-06
Terminated: 2007-08-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #43314. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.