FDA Device

TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, containing HBV Quantitation Standard (HBV QS).

Hazard

Low level of recombinant HIV DNA found in one lot of HBV QS which is a component of one lot of the TaqMan HBV ASR.

What You Should Do

Remedy

Notification letter to LabCorp wa sent on 2/14/2005 via FedEx.

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Products

TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, containing HBV Quantitation Standard (HBV QS).
Brand
Roche Molecular Systems Inc
UPC
TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, Lot F10185; HBV Quantitation Standard (HBV QS) Lot F10513.

Units Affected

450 sets

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