FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: MagNA Pure LC Instrument; Catalog number 2236931.
- Recall number
- Z-1044-03
- Recalling firm
- Roche Diagnostics Corp.
- Product
- MagNA Pure LC Instrument; Catalog number 2236931.
- Status
- Terminated
- Initiated
- 2003-06-26
- Posted
- 2003-07-23
- Terminated
- 2003-11-19
- Reason
- A software bug in version 3.0 may result in prolonged mixing time, evaporation of elution volume and biased sample results for various protocols.
- Root cause
- Other
- Action
- An urgent product correction letter dated 6/26/03 was sent to each customer advising them not to use DNA protocols until the software update has been installed.
- Quantity
- 17
- Distribution
- Nationwide and Canada California, Georgia, Illinois, Maine, Michigan, Mississippi, New York, Ohio, Oregon, Pennsylvania, Texas, Utah, Wisconsin and Canada.
- Lot, serial or model codes
- All systems using software version 3.0
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- 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