FDA Medical Device Recalls (openFDA)
Roche Molecular Systems Inc: TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, containing HBV Quantitation Standard (HBV QS).
- Recall number
- Z-0983-05
- Recalling firm
- Roche Molecular Systems Inc
- Product
- TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, containing HBV Quantitation Standard (HBV QS).
- Status
- Terminated
- Initiated
- 2005-02-14
- Posted
- 2005-07-13
- Terminated
- 2006-10-03
- Reason
- 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.
- Root cause
- Other
- Action
- Notification letter to LabCorp wa sent on 2/14/2005 via FedEx.
- Quantity
- 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.
- Lot, serial or model codes
- TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, Lot F10185; HBV Quantitation Standard (HBV QS) Lot F10513.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MVU
- Firm FEI
- 2243471
- Firm city
- Somerville
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28