Roche Diagnostics Corp. Roche brand OMNI 7 clinical chemistry analyzer; catalog numbers GD0435 and GD0435R. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Roche brand OMNI 7 clinical chemistry analyzer; catalog numbers GD0435 and GD0435R.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
All units with software version 5.61 or below.
Products Sold
All units with software version 5.61 or below.
Roche Diagnostics Corp. is recalling Roche brand OMNI 7 clinical chemistry analyzer; catalog numbers GD0435 and GD0435R. due to If the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sam. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
If the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume.
Recommended Action
Per FDA guidance
Consignees were notified by letter mailed on or about December 15, 2003. Customers are instructed to assure an adequate sample volume until new software becomes available.
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