Panoscreen I, II, and III 0002381Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10888234000303), received between Apr 26, 2017 and Jul 30, 2020 — classified as 7 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2020False Negative Result; False Negative Result

  THIS REPORT SUMMARIZES MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT ONE (1) PATIENT SAMPLE TEST USING PANOSCREEN III REAGENT ON AN AUTOMATED BLOOD BANK SYSTEMS PRODUCED AN UNEXPECTED NEGATIVE RESULT FOR THE ANTI-FYA ANTIBODY. THE RESULT REPRESENTED A FALSE NEGATIVE DUE TO PRIOR PATIENT HISTORY OR, TESTING COMPLETED BY OTHER METHODS THAT DEMONSTRATED THE PRESENCE OF THE SPECIFIC ANTIBODY. SUBSEQUENT TESTING OF THE REAGENT RETENTION LOT AND AN ANTIGEN VALIDATION TEST OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WAS DETERMINED FOR THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10345970 ↗
• MalfunctionJan 30, 2020False Negative Result; False Negative Result

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT 1 PATIENT SAMPLE TEST USING PANOSCREEN III REAGENT ON AN AUTOMATED BLOOD BANK SYSTEMS PRODUCED AN UNEXPECTED NEGATIVE RESULT FOR THE ANTI-FYB ANTIBODY. THE RESULT REPRESENTED A FALSE NEGATIVE DUE TO PRIOR PATIENT HISTORY OR, TESTING COMPLETED BY OTHER METHODS THAT DEMONSTRATED THE PRESENCE OF THE SPECIFIC ANTIBODY. SUBSEQUENT TESTING OF THE REAGENT RETENTION LOT AND AN ANTIGEN VALIDATION TEST OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WAS DETERMINED FOR THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9650129 ↗
• MalfunctionMar 13, 2019Inadequate or Insufficient Training; Inadequate or Insufficient Training

  ON (B)(6) 2019, A USER AT A CUSTOMER SITE REPORTED AN ACCIDENTAL EXPOSURE TO REAGENT RED BLOOD CELLS.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8416848 ↗
• MalfunctionOct 31, 2018False Negative Result; False Negative Result

  ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN USING PANOSCREEN, WHEN TESTED ON (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8023965 ↗
• MalfunctionJan 16, 2018False Negative Result; False Negative Result

  ON (B)(6) 2017, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN BY MANUAL TEST TUBE METHOD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7196044 ↗
• MalfunctionAug 16, 2017Output Problem

  ON (B)(6)2017, A CUSTOMER SITE REPORTED AN UNEXPECTED USER EXPOSURE TO PRODUCT.

  Patient problems: No Information

  MAUDE report 6797535 ↗
• MalfunctionApr 26, 2017False Negative Result

  ON (B)(6) 2017, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN TESTED BY MANUAL TEST TUBE METHOD WITH REAGENT RED BLOOD CELL ANTIBODY SCREENING CELLS, WHEN TESTED ON (B)(6) 2017.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6523231 ↗