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Terminated

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 Recall Z-0327-06 · Posted 2006-01-06

Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeLOM
Date Initiated2005-12-15
Date Terminated2007-08-07
Product Quantity436 kits

Reason for Recall

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

Firm Action

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.

Root Cause

Other

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.

Official Source

View FDA Recall →

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

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