Roche/Hitachi Modular Analytics System, Modular E Module GMMI immunoassay analyzer; Catalog numbers 04998642001 and 03617505001. Intended for qualitative and quantitative in vitro determinations using a wide variety of tests. Roche Diagnostics Corporation, 9115 Hague Road, Indianapolis, IN, 46250
FDA Recall Z-0868-2008 · Posted 2008-08-13
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Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeJJE
Date Initiated2008-03-21
Date Terminated2009-11-18
Product Quantity11 of all models.
Reason for Recall
Possible mismatch between patient and result.
Firm Action
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.
Root Cause
Process change control
Distribution Pattern
Nationwide Distribution --- including states of Florida, Georgia, Indiana, New Jersey and North Carolina.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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