API® 20 ERecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 03573026588489), received between Mar 16, 2018 and Nov 29, 2022 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (13 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Nov 9, 2022Open, Classified

   As the temperature and time out of range was exceeded, product performances cannot be guaranteed

   Z-0784-2023 · Root cause: Storage · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2022Unable to Obtain Readings; Unable to Obtain Readings

  INTENDED USE: API® 20 E IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE IDENTIFICATION OF ENTEROBACTERIACEAE AND OTHER NON-FASTIDIOUS GRAM-NEGATIVE RODS. IT USES MINIATURIZED TESTS AS WELL AS A SPECIALLY ADAPTED DATABASE. INOCULATION AND READING OF THE STRIP ARE PERFORMED MANUALLY AND THE IDENTIFICATION IS OBTAINED USING AN IDENTIFICATION SOFTWARE. THE COMPLETE LIST OF THOSE ORGANISMS THAT IT IS POSSIBLE TO IDENTIFY WITH THIS SYSTEM IS GIVEN IN THE TECHNICAL BROCHURE - INFORMATION FOR IDENTIFICATION SOFTWARE. A CUSTOMER IN ITALY REPORTED TO BIOMÉRIEUX AN ISSUE OF NO RESULT IN ASSOCIATION WITH THE PRODUCT API 20 E 25 STRIPS (REF: 20100, BATCH NUMBER: 1009005850, EXPIRY DATE: 22-FEB-2023). CUSTOMER STATED THAT WHEN INOCULATING SOME BACTERIAL STRAINS TO CONFIRM AN IDENTIFICATION CARRIED OUT ON ANOTHER INSTRUMENT (WALK AWAY), THEY NOTICED THAT ON THE API 20 E STRIPS WITH LOT 1009005850 THERE WAS NO COLOR CHANGE ON THE FIRST PART WHERE THE AUXILIARY REAGENTS ARE PLACED AND ON THE SECOND PART WHERE THE SECOND PART OF THE SUGARS REMAINED BLUE WITHOUT ANY COLOR CHANGE TO YELLOW. THE CLIENT HAD A SUSPICION OF SALMONELLA AND AS THEY HAD 4 OTHER PACKAGES OF A NEW BATCH OF API 20 E STRIPS (LOT#:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15876678 ↗
• MalfunctionAug 23, 2022Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  INTENDED USE: API® 20 E IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE IDENTIFICATION OF ENTEROBACTERIACEAE AND OTHER NON-FASTIDIOUS GRAM-NEGATIVE RODS. IT USES MINIATURIZED TESTS AS WELL AS A SPECIALLY ADAPTED DATABASE. ISSUE DESCRIPTION: A CUSTOMER IN SPAIN HAS NOTIFIED BIOMÉRIEUX THAT HE OBTAINED A MISIDENTIFICATION OF YERSINIA INTERMEDIA AS RAOULTELLA USING THE GALLERY API 20 E (REF. 20100, LOT NUMBER: 1008824240, EXPIRATION DATE: 07/12/2022). THE CUSTOMER HAS IDENTIFIED RAOULTELLA ORNITHINOLYTICA (98..9% ID) RATHER THAN YERSINIA INTERMEDIA (CECT 4317 / WDCM 00217). BIOMÉRIEUX CUSTOMER SERVICE DID NOT IDENTIFY ANY OFF-LABEL USE BY THE CUSTOMER WHILE PREPARING THE STRIP. AT THE TIME OF THE ASSESSMENT, THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15274921 ↗
• MalfunctionFeb 10, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CLIENT FROM (B)(6) NOTIFIED BIOM¿RIEUX OF A MISIDENTIFICATION OF LELLIOTTIA AMNIGENA (ENTEROBACTER AMNIGENUS) AS PANTOEA WHILE TESTING AN AGLAE PROFICIENCY SAMPLE WITH THE API¿ 20 E STRIP (REF. 20100, LOT NUMBER 1008041520). AN ALTERNATIVE TEST METHOD (MALDI IDENTIFICATION) WAS PERFORMED AND OBTAINED AN ORGANISM IDENTIFICATION TO LELLIOTTIA AMNIGENA. AS THIS WAS AN AGLAE PROFICIENCY SAMPLE, THERE IS NO PATIENT INVOLVED. A BIOM¿RIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 11308773 ↗
• MalfunctionJan 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM (B)(6) HAS NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION OF LELLIOTTIA AMNIGENA (ENTEROBACTER AMNIGENUS) AS PANTOEA WHILE TESTING AN AGLAE PROFICIENCY SAMPLE WITH THE API® 20 E 25STRIPS (REF 20100, LOT 1007955490) . MALDI-TOF TESTING WAS PERFORMED AS AN ALTERNATIVE METHOD AND OBTAINED AN IDENTIFICATION OF LELLIOTTIA AMNIGENA. GLOBAL CUSTOMER SERVICE (GCS) CONFIRMED THAT LELLIOTTIA AMNIGENA IS KNOWN AS ENTEROBACTER AMNIGENUS IN THE API® TECHNICAL LIBRARY AND CAN BE IDENTIFIED BY API® 20 E STRIPS. GCS REVIEWED THE DATA PROVIDED BY THE CUSTOMER AND IDENTIFIED THAT THE CUSTOMER OBTAINED SEVERAL ATYPICAL NEGATIVE TEST RESULTS AND AN ATYPICAL POSITIVE RESULT FOR AN IDENTIFICATION OF LELLIOTTIA AMNIGENA. AS THIS WAS AN AGLAE PROFICIENCY SAMPLE, THERE IS NO PATIENT INVOLVED. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 11208414 ↗
• MalfunctionNov 26, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INDUSTRY CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF OBTAINING AN INCORRECT RESULT IN ASSOCIATION WITH THE WITH API® 20 E STRIPS (REF. 20100, LOT 1007700960) WHILE PERFORMING QUALITY CONTROL TESTING WITH CECT SALMONELLA ENTERICA STRAIN. THE CUSTOMER STATED WHEN TESTING A SINGLE ISOLATED COLONY USING LOT 1007700960 NO GROWTH WAS OBSERVED IN THE STRIP AND A RESULT OF 0000000 (NEGATIVE) WAS OBTAINED. THE CUSTOMER RE-INCUBATED THE STRIP FOR ANOTHER TWENTY-FOUR (24) HOURS AT 36ºC; THE SAME RESULT OF 0000000(NEGATIVE) WAS OBTAINED. THE CUSTOMER PERFORMED OXIDASE TESTING ON THE SALMONELLA ENTERICA STRAIN AND CONFIRMED THE STRAIN WAS OXIDASE NEGATIVE. SALMONELLA ENTERICA WAS CULTURED ON TSI AND UREA AGAR; THE EXPECTED RESULTS WERE OBTAINED. THE CUSTOMER STATED WHEN TESTING THE STRAIN USING MULTIPLE COLONIES TO PREPARE THE CELL SUSPENSION, LOT 1007700960 OBTAINED THE CORRECT IDENTIFICATIONS. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMERIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

  Patient problems: No Patient Involvement

  MAUDE report 10908419 ↗
• MalfunctionNov 26, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INDUSTRY CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF OBTAINING INCORRECT RESULTS IN ASSOCIATION WITH THE WITH API® 20 E STRIPS (REF. 20100, LOT 1007700960) WHILE PERFORMING QUALITY CONTROL TESTING WITH CECT ESCHERICHIA COLI. THE CUSTOMER STATED WHEN TESTING A SINGLE ISOLATED COLONY USING LOT 1007700960 NO GROWTH WAS OBSERVED IN THE STRIP AND A RESULT OF 0000000 (NEGATIVE) WAS OBTAINED. THE CUSTOMER RE-INCUBATED THE STRIP FOR ANOTHER TWENTY-FOUR (24) HOURS AT 36ºC; THE SAME RESULT OF 0000000(NEGATIVE) WAS OBTAINED. THIS INCORRECT RESULT WAS OBTAINED FOR CECT ESCHERICHIA COLI. THE ESCHERICHIA COLI STRAIN WAS GRAM STAINED AND OBTAINED THE EXPECTED RESULT OF GRAM-NEGATIVE BACILLI. THE CUSTOMER STATED WHEN TESTING THE STRAIN USING MULTIPLE COLONIES TO PREPARE THE CELL SUSPENSION, LOT 1007700960 OBTAINED THE CORRECT IDENTIFICATION. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMERIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

  Patient problems: No Patient Involvement

  MAUDE report 10908390 ↗
• MalfunctionNov 19, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A LOW DISCRIMINATION RESULT WHILE TESTING A SALMONELLA ABORTUSOVIS NCTC QC STRAIN USING THE API ®20 E 25STRIPS (REFERENCE # 20100, LOT #1007630390). THE ORGANISM IS A NCTC (NATIONAL COLLECTION OF TYPE CULTURES) STRAIN OF SALMONELLA ABORTUSOVIS. THE RESULT OBTAINED WITH API 20 E STRIP WAS ¿LOW DISCRIMINATION¿ WITH YERSINIA PESTIS (81.9%), E. COLI (8.9%) AND SHIGELLA SPP. (8,5%) AS SIGNIFICANT TAXA AND SALMONELLA SER. TYPHI (0.2%). SALMONELLA ABORTUSOVIS IS NOT INCLUDED IN API 20 E DATABASE. PER GLOBAL CUSTOMER SERVICE (GCS) AND API EXPERTS, SALMONELLA ABORTUSOVIS WAS NOT TESTED DURING DEVELOPMENT; THEREFORE, THE IDENTIFICATION IS NOT POSSIBLE FOR THIS STRAIN AND IT'S NOT POSSIBLE TO HAVE AN IDENTIFICATION TO THE GENUS "SALMONELLA SPP". SALMONELLA SPP. IS IN THE DATABASE BUT ONLY APPLIES TO THOSE SPECIES OF SALMONELLA WHICH WERE TESTED WHEN THE DATABASE WAS CREATED. PER THE PACKAGE INSERT, "API® SYSTEMS IDENTIFY AN ORGANISM BY USING A METHODOLOGY BASED ON THE CHARACTERISTICS OF THE DATA AND KNOWLEDGE ABOUT THE ORGANISM AND REACTIONS BEING ANALYZED. SUFFICIENT DATA HAVE BEEN COLLECTED FROM KNOWN STRAINS TO ESTIMATE THE TYPICAL

  Patient problems: No Patient Involvement

  MAUDE report 10871841 ↗
• MalfunctionOct 19, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF YERSINIA BERCOVIERI AS YERSINIA ENTEROCOLITICA IN ASSOCIATION WITH THE API® 20 E 25STRIPS (REF 20100). THE LOT NUMBER WAS NOT PROVIDED. THE CUSTOMER STATED THAT THEY OBTAINED A VERY GOOD IDENTIFICATION OF YERSINIA ENTEROCOLITICA. THE STRAIN WAS SENT TO THE INSTITUT PASTEUR WHERE THE IDENTIFICATION WAS DETERMINED TO BE YERSINIA BERCOVIERI VIA MALDI-TOF ANALYSIS. API 20 E: YERSINIA ENTEROCOLITICA, MALDI-TOF: YERSINIA BERCOVIERI. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10697386 ↗
• MalfunctionOct 7, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED AFTER COMPLETION OF AN INVESTIGATION INDICATED THAT A CUSTOMER HAD OBTAINED A MISIDENTIFICATION OF KLEBSIELLA OXYTOCA AS KLEBSIELLA PNEUMONIAE IN ASSOCIATION WITH THE API® 20 E 25 STRIPS (REF (B)(4)). THE CUSTOMER INITIALLY REPORTED A COMPLAINT AGAINST VITEK® 2 GN ID CARDS (REF. (B)(4)). BIOMÉRIEUX INITIATED AN INVESTIGATION AND CONFIRMED THAT THE VITEK® 2 GN ID CARD RESULTS WERE CORRECT, AND THE CUSTOMER¿S STRAIN WAS KLEBSIELLA OXYTOCA. BIOMÉRIEUX CREATED A COMPLAINT AGAINST THE API® 20 E (REF. (B)(4). THE CUSTOMER OBTAINED THE FOLLOWING RESULTS: VITEK® 2 GN ID CARD = KLEBSIELLA OXYTOCA; API® 20 E = KLEBSIELLA PNEUMONIAE; ISOLATE TESTED AS INDOLE NEGATIVE. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION FOR THE API® 20 E MISIDENTIFICATION HAS BEEN INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10641165 ↗
• MalfunctionJun 17, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A 2019 SCIENTIFIC PUBLICATION ENTITLED, "CHALLENGES IN IDENTIFICATION OF ENTEROINVASIVE ESCHERICHIA COLI AND SHIGELLA SPP. IN LEBANON" BY HALIMEH F., ET AL. THE PURPOSE OF THE STUDY WAS TO EVALUATE TOOLS AVAILABLE IN LEBANON TO DIFFERENTIATE BETWEEN ESCHERICHIA COLI AND SHIGELLA SPP. DIARRHEAL DISEASES ARE A MAJOR PUBLIC HEALTH ISSUE WORLDWIDE AND ESCHERICHIA COLI AND SHIGELLA SPP. ARE TWO OF THE MOST COMMON CAUSES. ESCHERICHIA COLI AND SHIGELLA SPP. ARE VERY SIMILAR GENETICALLY WHICH MAKES IT HARD TO DIFFERENTIATE BETWEEN THEM. THE API ® 20 E (REFERENCE # 20100) WAS ONE OF THE TOOLS USED IN THE STUDY ALONG WITH MALDI-TOF, SEROLOGICAL TESTING, DUPLEX PCR TARGETING IPAH (PRESENT IN SHIGELLA SPP. AND ENTEROINVASIVE E. COLI "EIEC") AND LACY (FOUND IN E. COLI INCLUDING EIEC BUT NOT SHIGELLA SPP.) AS WELL AS GYRB GENE SEQUENCING. ANTIBIOTIC SUSCEPTIBILITY WAS INVESTIGATED AS WELL AS SHIGA-TOXIN PRODUCTION. THE API ® 20 E IDENTIFIED 43 ISOLATES FROM STOOL SAMPLES COLLECTED FROM JULY 2010 TO SEPTEMBER 2016 AS SHIGELLA SPP. BUT GYRB GENE SEQUENCING METHOD IDENTIFIED THEM AS E. COLI. THE LAB USED SEROLOGICAL AND MOLECULAR ANALYSIS (P

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10162703 ↗
• MalfunctionJan 6, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING NO IDENTIFICATION RESULT WHEN TESTING INTERNAL QC STRAINS WITH THE API® 20 E (REF 20100, LOT 1007490280). THE ISSUE WAS OBSERVED DURING A TRAINING SESSION WITH QC STRAINS. AS THIS WAS A TRAINING SESSION WITH QC STRAINS, THERE IS NO PATIENT INVOLVED. THE CUSTOMER REPORTED THAT TUBES ON THE API® 20 E STRIPS DRIED OUT AND NO RESULT COULD BE OBTAINED. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 9555651 ↗
• MalfunctionDec 27, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING NO IDENTIFICATION RESULT WHEN TESTING INTERNAL QC STRAINS WITH THE API® 20 E (REF 20100, LOT 1007437810). THE ISSUE WAS OBSERVED DURING A TRAINING SESSION WITH QC STRAINS. AS THIS WAS A TRAINING SESSION WITH QC STRAINS, THERE IS NO PATIENT INVOLVED. THE CUSTOMER REPORTED THAT TUBES ON THE API® 20 E STRIPS DRIED OUT AND NO RESULT COULD BE OBTAINED. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 9527462 ↗
• MalfunctionNov 7, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE CITRATE RESULTS FOR ESCHERICHIA COLI (E. COLI) ATCC® 25922 IN ASSOCIATION WITH API® 20 E 25 STRIPS (REF. 20100, LOT 1006601250). THE CUSTOMER PERFORMED TESTING FOUR (4) TIMES USING API® 20 E 25STRIPS LOT 1006601250 WITH TWO (2) STRAINS OF E. COLI ATCC® 25922 AND OBTAINED A POSITIVE RESULT FOR ALL ASSAYS. E. COLI ATCC® 25922 WAS ALSO TESTED IN PARALLEL USING API® 20 E 25STRIPS LOT 1006611730, AND OBTAINED A NEGATIVE CITRATE RESULT. THE CUSTOMER CONFIRMED THE EXPECTED CITRATE RESULT FOR E. COLI ATCC® 25922 IS NEGATIVE. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Patient Involvement

  MAUDE report 9293357 ↗
• MalfunctionMar 16, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT THE OCCURRENCE OF A MISIDENTIFICATION OF RAOULTELLA PLANTICOLA (EXTERNAL QC STRAIN) AS KLEBSIELLA PNEUMONIA IN ASSOCIATION WITH THE API® 20E TEST. NO ALTERNATE TEST METHOD OR CONFIRMATORY TESTING WAS PERFORMED BY THE CUSTOMER. THE EXTERNAL QC TESTING WAS PERFORMED ONE YEAR AGO; THE STRAIN IS NO LONGER AVAILABLE FOR RETEST. PRIOR TO 2001, THE NAME OF RAOULTELLA PLANTICOLA WAS KLEBSIELLA PLANTICOLA. THE BIOCHEMICAL CHARACTERISTICS BETWEEN RAOULTELLA PLANTICOLA AND KLEBSIELLA PNEUMONIA ARE SIMILAR. IT IS IMPORTANT TO NOTE THAT RAOULTELLA PLANTICOLA IS NOT IN THE API® 20E DATABASE; THEREFORE, IT IS NOT POSSIBLE TO IDENTIFY RAOULTELLA PLANTICOLA THEAPI® 20E TEST STRIP. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THERE WAS NO PATIENT DIRECTLY ASSOCIATED WITH THE QC STRAIN. BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7344955 ↗