FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Roche MagNA Pure LC Instrument Kit; Catalog no. 12236931001. An automated, general purpose instrument for isolation and purification of nucleic acids and assembly of PCR reactions.
- Recall number
- Z-1373-06
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Roche MagNA Pure LC Instrument Kit; Catalog no. 12236931001. An automated, general purpose instrument for isolation and purification of nucleic acids and assembly of PCR reactions.
- Status
- Terminated
- Initiated
- 2006-07-17
- Posted
- 2006-08-05
- Terminated
- 2007-12-04
- Reason
- If the user opens the instrument lid during decontamination, the cycle will stop but the timer will continue resulting in the user believing the instrument has been decontaminated when it has not been.
- Root cause
- Other
- Action
- Consignees were notified via recall letter dated 7/17/06 to restart the sterilization cycle if they open the instrument for any reason during the sterilization cycle.
- Quantity
- 771 total for recalls Z-1372-1374-06
- 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