FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular P800 Module, Roche Diagnostics Corp., Indpls., IN; GMMI No. 04998669001. Is a fully automatic, computerized chemistry analyzer intended for in vitro quantitative and qualitative determinations of a wide range analytes. The instrument is capable of performing potentiometric and photometric assays.
- Recall number
- Z-1066-2009
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular P800 Module, Roche Diagnostics Corp., Indpls., IN; GMMI No. 04998669001. Is a fully automatic, computerized chemistry analyzer intended for in vitro quantitative and qualitative determinations of a wide range analytes. The instrument is capable of performing potentiometric and photometric assays.
- Status
- Terminated
- Initiated
- 2008-11-12
- Posted
- 2009-04-10
- Terminated
- 2009-09-22
- Reason
- If a masked module is unmasked during the reagent registration process, the calibration parameters may be assigned to the wrong reagents, resulting in the reporting of incorrect control and sample results.
- Root cause
- Software change control
- Action
- Consignees were notified via an Urgent Medical Device Correction letter dated 11/12/08 and instructed to only execute "module unmasking" when the unit is in "standby" mode and to consult with their physicians at the facility to determine the clinical implications and whether any clinical intervention is needed for patients treated based upon results obtained with this software. Questions should be directed to Roche Diagnostics Technical Support at 1-800-428-2336.
- Quantity
- 22 systems in all
- Distribution
- Nationwide Distribution -- including states of California, Florida, Georgia, Hawaii, Indiana, Maryland, New York, North Carolina, Pennsylvania, and Virginia.
- Lot, serial or model codes
- All units with software version 08-03.
- 510(k) numbers
- ["K953239"]
- 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