reditest® 011020119Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10858904006317), received between Jan 24, 2018 and Nov 15, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2018False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FOUR OCCURRENCES OF FALSE POSITIVE COC, MAMP, AND OPI RESULTS USING THE MULTI-DRUG 6 PANEL SCREEN TEST ON MULTIPLE DONORS. CONFIRMATORY TESTING AT A LABORATORY PROVIDED NEGATIVE RESULTS. THE FALSE POSITIVE RESULTS OCCURRED ON FOUR OUT OF FOUR DEVICES USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8075630 ↗
• MalfunctionFeb 26, 2018False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING UNCONFIRMED FALSE POSITIVE RESULTS FOR ALL ANALYTES USING THE MULTI-DRUG ONE STEP 6 DRUG SCREEN TEST PANEL. THE UNCONFIRMED FALSE POSITIVE RESULTS OCCURRED ON DIFFERENT RANDOM DONORS. THE UNCONFIRMED FALSE POSITIVE RESULTS OCCURRED ON 23 DEVICES OUT OF 25 DEVICES USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7298223 ↗
• MalfunctionJan 24, 2018False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A FALSE POSITIVE THC AND MAMP RESULT ON ONE DONOR USING A MULTI-DRUG ONE STEP 6 DRUG SCREEN TEST PANEL. THE CUSTOMER ALSO REPORTED RECEIVING A FALSE POSITIVE COC, MAMP, THC, AND BZO RESULT ON A SECOND DONOR USING ANOTHER MULTI-DRUG ONE STEP 6 DRUG SCREEN TEST PANEL. THE FALSE POSITIVE RESULTS OCCURRED ON 2 DEVICES OUT OF 100 DEVICES USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7215917 ↗