IMPAX RIS QDOC 5.8
FDA Recall Z-0919-2014 · Posted 2014-02-03
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Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2014-01-08
Date Terminated2014-02-28
Product Quantity14
Reason for Recall
Patient name displayed (printed) on the Patient Report was the wrong patient name.
Firm 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.
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
CA, FL, GA, ME, OH, OR, SC, SD, TX and Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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