Vitros Immunodiagnostic HBsAg CONFIRMATORY KIT * REF 680 1324. Firm on label: Ortho-Clinical Diagnostics, 62 The Broadwa
FDA device recall Z-0327-06 · posted 2006-01-06 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- 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'.
- Action taken
- 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
- Status
- Terminated
- Product code
- LOM
- Quantity affected
- 436 kits
- Distribution
- 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.
- Date initiated
- 2005-12-15
- Date posted
- 2006-01-06
- Date terminated
- 2007-08-07
- Location
- Rochester, NY
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