reditest® 011020188Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10858904006430), received between Jan 16, 2019 and Jan 16, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “False Positive Result” (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.

• MalfunctionJan 16, 2019False Positive Result; False Positive Result

  ON (B)(6) 2018: FALSE POSITIVE COC AND MAMP 1X ON THE MULTI-DRUG 12 PANEL SCREEN NO FURTHER TESTING OR LAB TESTING WAS PERFORMED. OPERATOR EXPLAINED THEY THINK THIS DONOR SHOULD BE NEGATIVE AND THAT THIS TEST WAS A FALSE POSITIVE. OPERATOR DID NOT PROVIDE JUSTIFICATION FOR WHY THEY THINK THIS DONOR SHOULD BE NEGATIVE. NO TREATMENT WAS PROVIDED OR WITHHELD BASED ON THE FALSE POSITIVE RESULTS. NO ADVERSE OUTCOMES REPORTED. NO ALLEGED DELAY IN TREATMENT AS A RESULT OF THE FALSE POSITIVE RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8254948 ↗