Roche Diagnostics Corp. COBAS Gui software interface between the Cobas AMPLICOR instrument and the Tecan clinical workstation (Tecan Genesis 150/8 front end COBAS), Roche catalog number 04498984001. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
COBAS Gui software interface between the Cobas AMPLICOR instrument and the Tecan clinical workstation (Tecan Genesis 150/8 front end COBAS), Roche catalog number 04498984001.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
All units (serial numbers 6178, 7629, 7698, 7744, 7753, 7754, 7755 and 7768 .
Products Sold
All units (serial numbers 6178, 7629, 7698, 7744, 7753, 7754, 7755 and 7768 .
Roche Diagnostics Corp. is recalling COBAS Gui software interface between the Cobas AMPLICOR instrument and the Tecan clinical workstatio due to The Roche COBAS interface driver for the Tecan software may assign sample results to the wrong patient.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The Roche COBAS interface driver for the Tecan software may assign sample results to the wrong patient.
Recommended Action
Per FDA guidance
Press release was issued 5/7/04 and recall letter dated 5/5/04 was sent to each user consignee.
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 noticeDistribution
As reported by FDA
CA, CT, IL, MA, PA, TX, WI
Page updated: Jan 10, 2026