FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Roche MagNA Pure LC System. An automated, general purpose instrument for isolation and purification of nucleic acids and assembly of PCR reactions. Catalog numbers 12236931001 and 03670325001
- Recall number
- Z-0774-06
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Roche MagNA Pure LC System. An automated, general purpose instrument for isolation and purification of nucleic acids and assembly of PCR reactions. Catalog numbers 12236931001 and 03670325001
- Status
- Terminated
- Initiated
- 2006-04-04
- Posted
- 2006-04-19
- Terminated
- 2006-07-03
- Reason
- The firm has received complaints of reagent splattering on the deck of the instrument and possible cross contamination of samples purified on the instrument.
- Root cause
- Other
- Action
- Consignees were notified by letter dated 4/4/06 to notify customers of the problem and provide a work-around.
- Quantity
- 251
- Distribution
- Nationwide.
- Lot, serial or model codes
- All units.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NPQ
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- 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