Roche Diagnostics Corp. Roche/Hitachi Modular Analytics System, Modular D2400 Module GMMI clinical chemistry analyzer; Catalog number 04998618001. Intended for qualitative and quantitative in vitro determinations using a wide variety of tests. Roche Diagnostics Corporation, 9115 Hague Road, Indianapolis, IN, 46250 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Roche/Hitachi Modular Analytics System, Modular D2400 Module GMMI clinical chemistry analyzer; Catalog number 04998618001. Intended for qualitative and quantitative in vitro determinations using a wide variety of tests. Roche Diagnostics Corporation, 9115 Hague Road, Indianapolis, IN, 46250
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
All units with software version 08-02.
Products Sold
All units with software version 08-02.
Roche Diagnostics Corp. is recalling Roche/Hitachi Modular Analytics System, Modular D2400 Module GMMI clinical chemistry analyzer; Catal due to Possible mismatch between patient and result.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Possible mismatch between patient and result.
Recommended Action
Per FDA guidance
Consignees were notified via Urgent Medical Device Correction letter dated 3/21/08, which instructed them to not manually order QC test selections while the system is in operation mode and that they can only manually order QC when the system is in Stand-by mode. Consignees are instructed to consult with their physicians or pathologist to determine specific clinical implications for their patients. The firm states that this issue will be resolved in the next version of software.
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