Roche Diagnostics Corp. Tecan clinical workstation; 10-410 Tecan Genesis 150 back end, Roche catalog number 03585352001. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Tecan clinical workstation; 10-410 Tecan Genesis 150 back end, Roche catalog number 03585352001.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
All units (serial numbers 5583, 5606, 6372, 6394, 6396, 6398, 6558, 7210, 7574, 7595 and 7615).
Products Sold
All units (serial numbers 5583, 5606, 6372, 6394, 6396, 6398, 6558, 7210, 7574, 7595 and 7615).
Roche Diagnostics Corp. is recalling Tecan clinical workstation; 10-410 Tecan Genesis 150 back end, Roche catalog number 03585352001. due to Tecan software has the potential to match the patient with a different patient's test results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Tecan software has the potential to match the patient with a different patient's test results.
Recommended Action
Per FDA guidance
Press release was issued 5/7/04 and recall letter dated 5/5/04 was sent to user laboratories.
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