FDA Recall
Terminated
IMPAX RIS QDOC 5.8
Recall: Z-0919-2014
·
Initiated January 8, 2014
Recall
- Recall Number
- Z-0919-2014
- Event Number
- 67275
- Firm
- AGFA Corp.
- FEI Number
- 3001236302
- Product Code
- LLZ
- Status
- Terminated
- Root Cause
- Unknown/Undetermined by firm
- Initiated
- January 8, 2014
- Posted
- February 3, 2014
- Terminated
- February 28, 2014
- Address
- 10 S Academy St, Greenville, SC, 29601-2632
Description
IMPAX RIS QDOC 5.8
Reason
Patient name displayed (printed) on the Patient Report was the wrong patient name.
Action
On January 8, 2014, an "URGENT FIELD SAFETY NOTICE" (UFSN) letter was emailed to consignees. The letter described the safety alert and mitigation, including directions to consignees as to how the disable Microsoft Word Background Printing. Acknowledgment via FAX-Back or email, that the information was received and understood was requested from the consignees.
Distribution
CA, FL, GA, ME, OH, OR, SC, SD, TX and Canada
Quantity
14