Roche Molecular Systems Inc TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, containing HBV Quantitation Standard (HBV QS). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, containing HBV Quantitation Standard (HBV QS).
Brand
Roche Molecular Systems Inc
Lot Codes / Batch Numbers
TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, Lot F10185, HBV Quantitation Standard (HBV QS) Lot F10513.
Products Sold
TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, Lot F10185; HBV Quantitation Standard (HBV QS) Lot F10513.
Roche Molecular Systems Inc is recalling TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, containing HBV Quantitation Standar due to 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.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Notification letter to LabCorp wa sent on 2/14/2005 via FedEx.
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 noticeDistribution
As reported by FDA
NC
Page updated: Jan 10, 2026