Tecan Clinical Workstations with Robonet software
This recall has been terminated (originally issued July 20, 2004).
- Company
- Tecan U S Inc
- Recall Initiated
- May 3, 2004
- Posted
- July 20, 2004
- Terminated
- May 17, 2005
- Recall Number
- Z-1022-04
- Quantity
- 44 units (hardware), 33 units (software)
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
Reason for Recall
Tecan software has the potential to match the patient with a different patient's test results.
Distribution
CA, CT, GA, IL, IN, MA, MD, MI, NJ, NY, PA, TN, TX, VA, & WI.
Lot / Code Info
PN 10-410 Tecan Genesis 150/8 Back End Configuration, PN 10-415 Tecan Genesis 150/8 Front End Configuration, PN 10-309 Tecan Genesis 200/8 Workstation, PN 10-307 Tecan Genesis 150/8 Workstation, PN 10-043A Tecan Genesis RSP 150/8, PN 10-040A Tecan Genesis RSP 100/4, PN 10-401A Tecan Genesis RSP 100/8,
Root Cause
Other
Action Taken
Consignees were notified by letter on May 3, 2004