Roche Diagnostics Corp. Roche/Hitachi Modular Analytics System, clinical chemistry analyzer Modular D2400 Module, Roche Diagnostics Corp., Indpls., IN; GMMI No. 04998618001. 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Roche/Hitachi Modular Analytics System, clinical chemistry analyzer Modular D2400 Module, Roche Diagnostics Corp., Indpls., IN; GMMI No. 04998618001. 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.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
All units with software version 08-03.
Products Sold
All units with software version 08-03.
Roche Diagnostics Corp. is recalling Roche/Hitachi Modular Analytics System, clinical chemistry analyzer Modular D2400 Module, Roche Dia due to If a masked module is unmasked during the reagent registration process, the calibration parameters may be assigned to the wrong reagents, resulting in. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026