Roche Diagnostics Corp. Roche/Hitachi 747 - 200 clinical chemistry analyzer; catalog number 04009223680. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Roche/Hitachi 747 - 200 clinical chemistry analyzer; catalog number 04009223680.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
All units.
Products Sold
All units.
Roche Diagnostics Corp. is recalling Roche/Hitachi 747 - 200 clinical chemistry analyzer; catalog number 04009223680. due to A software defect will allow the reporting out of believable, but clinically significant, erroneous results under certain conditions.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A software defect will allow the reporting out of believable, but clinically significant, erroneous results under certain conditions.
Recommended Action
Per FDA guidance
Recall letters dated 8/6/04 were sent to each customer advising them of the problem and giving instructions on how to avoid it.
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