Roche Diagnostics Corp. Tecan clinical workstation; Tecan Genesis 150 front end, Roche catalog number 03585379001. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Tecan clinical workstation; Tecan Genesis 150 front end, Roche catalog number 03585379001.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
Serial numbers 5524, 6177, 6224, 6376, 6393, 6395, 6397, 6557, 7150, 7349, 7350, 7594, 7616 and 7724.
Products Sold
Serial numbers 5524, 6177, 6224, 6376, 6393, 6395, 6397, 6557, 7150, 7349, 7350, 7594, 7616 and 7724.
Roche Diagnostics Corp. is recalling Tecan clinical workstation; Tecan Genesis 150 front end, Roche catalog number 03585379001. due to If the files are not periodically purged from the TCW computer, it may result in patient identification/sample results mismatches.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
If the files are not periodically purged from the TCW computer, it may result in patient identification/sample results mismatches.
Recommended Action
Per FDA guidance
Roche sent each of their consignees revised Tecan database maintenance instruction via bulletin 04-042 dated 3/5/04.
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