PakPlus®Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888234500254), received between Feb 8, 2018 and Feb 8, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER COMPLAINT ((B)(4)) WAS RECEIVED 09 JAN 2018. ON (B)(6) 2017, CUSTOMER TESTED FRESH PATIENT SAMPLE WITH LOT 3005747 OF PAKPLUS AND RECEIVED A NEGATIVE RESULT FOR WELL A. CUSTOMER RECEIVED NEW LOT OF PAKPLUS 3006225 ON (B)(6) 2018. ON (B)(6) 2018, CUSTOMER TESTING WITH LOT 3006225 OF PAKPLUS ON A PATIENT ALIQUOT FROM (B)(6) 2017. THE RESULT FOR WELL A WAS POSITIVE. CUSTOMER ALSO TESTED ANOTHER PATIENT ALIQUOT COLLECTED FROM (B)(6) WITH LOT 3005747 AND WELL A WAS NEGATIVE. TESTING WAS REPEATED ON (B)(6) 2018 USING BOTH LOTS. LOT 3005747 RESULTED IN WELL A NEGATIVE AND LOT 3006225 RESULTED IN WELL A POSITIVE. CUSTOMER REPORTED NEGATIVE RESULTS ON THE PATIENT FROM THE INITIAL TESTING.

  Patient problems: No Information

  MAUDE report 7257347 ↗