Z-0983-05

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

Name: Z-0983-05 TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, containing HBV Quantitation Standard (HBV QS)
Creator: Roche Molecular Systems Inc
Published: 2005-02-14
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2005-02-14 / Terminated

FDA source

Roche Molecular Systems Inc began a recall of TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, containing HBV Quantitation Standard (HBV QS) on 2005-02-14. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0983-05
Status: Terminated
Initiated: 2005-02-14
Posted: 2005-07-13
Terminated: 2006-10-03
Recalling firm: Roche Molecular Systems Inc
Product: TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, containing HBV Quantitation Standard (HBV QS).
Product code: MVU Reagents, Specific, Analyte
Reason for recall: 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.
FDA root cause: Other
Action: Notification letter to LabCorp wa sent on 2/14/2005 via FedEx.
Quantity in commerce: 450 sets
Distribution: One customers received 14 kits on 1/3/2005. This one customer was LabCorp, 1912 Alexander Drive, Research Triangle Park, NC 27709.
Product codes and lots: TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, Lot F10185; HBV Quantitation Standard (HBV QS) Lot F10513.

Product code MVU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)