RAPID 20 E™Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03573026588526), received between Sep 17, 2019 and Oct 27, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2021Device Markings/Labelling Problem; Inaccurate Information; Device Markings/Labelling Problem; Inaccurate Information

  A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX REGARDING AN INTERPRETATION QUESTION IN ASSOCIATION WITH THE API RAPID 20 E¿ TEST STRIPS (REF. 20701, LOT 1008047921). THE CUSTOMER QUESTIONED THE COLOR INTERPRETATION OF THE CIT WELL IN THE RAPID 20 E¿ TEST STRIP WHEN TESTING A QUALITY CONTROL S. ENTEREDITIS ATCC® 13076¿ AND PROTEUS HAUSERI ATCC® 13315¿ ISOLATES, WITH EXPECTED RESULT OF CIT POSITIVE (GREEN TO BLUE) AND CIT NEGATIVE (YELLOW), RESPECTIVELY. THE RAPID 20 E¿ TEST STRIP PACKAGE INSERT VERSION G STATES "YELLOW" RESULTS ARE INTERPRETED AS NEGATIVE WHILE A "GREEN TO BLUE" RESULT IS POSITIVE. THE CUSTOMER OBTAINED THE EXPECTED POSITIVE RESULT FOR S. ENTEREDITIS ATCC® 13076¿; HOWEVER, THE CIT WELL FOR PROTEUS HAUSERI ATCC® 13315¿ WAS GREEN-YELLOW IN COLOR. THE CUSTOMER ASKED IF THIS WAS AN INCORRECT RESULT AS THE PREVIOUS VERSION OF THE PACKAGE INSERT (VERSION F) STATED A CIT WELL OF "YELLOW TO YELLOW-GREEN'" WAS CONSIDERED A NEGATIVE RESULT. BIOMÉRIEUX CUSTOMER SERVICE AND LABELING DEPARTMENTS CONFIRMED AN ERROR IN THE PACKAGE INSERT READING TABLE (VERSION G). THEY CONFIRMED THE NEGATIVE RESULT COLOR FOR CIT TEST SHOULD BE "YELLOW TO YELLOW-GREEN", AS IN THE PREVIOUS PACKAGE INSERT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12705936 ↗
• MalfunctionSep 17, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INDUSTRY CUSTOMER FROM (B)(6) REPORTED A MISIDENTIFICATION OF SERRATIA MARCESCENS AS SERRATIA LIQUEFACIENS WHEN TESTING A QC STRAIN WITH API® RAPID 20 E 25STRIPS (REF. 20701) - LOT 1005589130. THE CUSTOMER STATED THEY TESTED A KNOWN SERRATIA MARCESCENS STRAIN AND RECEIVED AN IDENTIFICATION OF 95.5% S.LIQUEFACIENS (AND 3.9% S.MARCENSCENS). THE CUSTOMER ALSO USED SEQUENCING ON THIS STRAIN TO OBTAIN A PHYLOGENETIC TREE. THE SEQUENCING CONFIRMED THAT THE STRAIN WAS NOT S.LIQUEFACIENS. THE CUSTOMER THEN REPEATED THE RAPID 20 E TEST AND OBTAINED SERRATIA MARCESCENS. THERE WAS NO PATIENT INVOLVED AS THIS EVENT PERTAINS TO AN INDUSTRY QC. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 9076609 ↗