FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642001 and 03617505001.
- Recall number
- Z-0165-2009
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642001 and 03617505001.
- Status
- Terminated
- Initiated
- 2008-06-24
- Posted
- 2008-10-22
- Terminated
- 2009-10-22
- Reason
- A software bug may result in pipetting from an incorrect reagent pack and/or assigning calibration curve parameters incorrectly.
- Root cause
- Other
- Action
- The consignees were notified of the problem via letter dated 6/24/08 and were provided instructions for a workaround.
- Quantity
- not on file
- Distribution
- Nationwide Distribution --- including states of Florida, New Jersey and North Carolina.
- Lot, serial or model codes
- All units with software version 08-02.
- 510(k) numbers
- ["K961481"]
- PMA numbers
- not on file
- Product code
- JJE
- 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