Ortho-Clinical Diagnostics 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Ortho-Clinical Diagnostics
Lot Codes / Batch Numbers
Lot 5140, exp. 4/13/2006, Lot 5150, exp. 5/31/2006, and Lot 5160, exp. 7/3/2006
Products Sold
Lot 5140, exp. 4/13/2006; Lot 5150, exp. 5/31/2006; and Lot 5160, exp. 7/3/2006
Ortho-Clinical Diagnostics is recalling Vitros Immunodiagnostic HBsAg CONFIRMATORY KIT * REF 680 1324. Firm on label: Ortho-Clinical Diagn due to Increased background signal of the sample diluent in the affected Confirmatory Kits could cause some results to be classified as 'Not Confirmed'.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Increased background signal of the sample diluent in the affected Confirmatory Kits could cause some results to be classified as 'Not Confirmed'.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026