API® LISTERIA 10300Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03573026035587), received between Mar 26, 2020 and Oct 10, 2023 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (10 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. How this data works · Data updated Oct 13, 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-0783-2023 · Root cause: Storage · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2023Unable to Obtain Readings; Unable to Obtain Readings

  INTENDED USE: API® LISTERIA IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE IDENTIFICATION OF LISTERIA. 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. ISSUE DESCRIPTION: AN INDUSTRY CUSTOMER FROM FRANCE NOTIFIED BIOMÉRIEUX OF UNACCEPTABLE PROFILE RESULT OBTAINED WITH LISTERIA MONOCYTOGENES IN ASSOCIATION WITH API LISTERIA 10 STRIPS+10MEDIA - 10300, LOT# 1010042770, EXP DATE: 3/21/2024. A RELATED COMPLAINT (B)(4) WAS CREATED TO DOCUMENT THE SAME ISSUE OBTAINED BY THE SAME CUSTOMER, SAME PRODUCT BUT DIFFERENT LOT NUMBER. RESULTS ARE SUMMARIZED BELOW: API LISTERIA (REF:10300) : 2 LOTS : 009868240 AND 1010042770. MATRIX: CUSTOMER 1: BUTTER AND RAW FRESH TOMME CHEESE MATRIX CUSTOMER 2 EIL REYMA: MILK POWDER: SAMPLES 852352, 674064 AND 888865 MALDI-TOF VERIFICATION: PROFILE MATCHES LISTERIA MONOCYTOGENES FOR ALL 6 STRAINS. CUSTOMER REPORTED THAT ON SEVERAL GALLERIES OF THE ABOVE-MEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17903257 ↗
• MalfunctionOct 10, 2023Unable to Obtain Readings; Unable to Obtain Readings

  INTENDED USE: API® LISTERIA IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE IDENTIFICATION OF LISTERIA. 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. ISSUE DESCRIPTION: AN INDUSTRY CUSTOMER FROM FRANCE NOTIFIED BIOMÉRIEUX OF UNACCEPTABLE PROFILE RESULT OBTAINED WITH LISTERIA MONOCYTOGENES IN ASSOCIATION WITH API LISTERIA 10STRIPS+10MEDIA - 10300, LOT. 1009868240, EXP DATE: 11/24/2023). A RELATED COMPLAINT (B)(4) WAS CREATED TO DOCUMENT THE SAME ISSUE OBTAINED BY THE SAME CUSTOMER, SAME PRODUCT BUT DIFFERENT LOT NUMBER. RESULTS ARE SUMMARIZED BELOW: API LISTERIA -REF:10300-(LOTS : 009868240 AND 1010042770) MATRIX: CUSTOMER 1: BUTTER AND RAW FRESH TOMME CHEESE MATRIX CUSTOMER 2 EIL REYMA: MILK POWDER: SAMPLES (B)(6). MALDI-TOF VERIFICATION: PROFILE MATCHES LISTERIA MONOCYTOGENES FOR ALL 6 STRAINS. CUSTOMER REPORTED THAT ON SEVERAL GALLERIES OF THE ABOVE-MENTIONED BATCHES, THEY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17903255 ↗
• MalfunctionFeb 7, 2023False Positive Result; False Positive Result

  INTENDED USE: API® LISTERIA IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE IDENTIFICATION OF LISTERIA. 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. DESCRIPTION OF THE ISSUE A CUSTOMER IN UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION WHEN USING THE API LISTERIA 10STRIPS+10MEDIA - REFERENCE 10300 ( LOT NOT SPECIFIED). INDEED, THE CUSTOMER MENTION OF HAVING OBTAINED A FALSE POSITIVE WITH XYL TEST. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO OR CONTRIBUTED TO ANY DEATH, SERIOUS INJURY, OR SERIOUS DETERIORATION IN THE STATE OF HEALTH FOR THE CONCERNED PATIENT. THIS EVENT HAS BEEN REVIEWED FOR VIGILANCE REPORTING IN ACCORDANCE WITH 21 CFR 803, CONCERNING MEDICAL DEVICE REPORTING. PER BIOMÉRIEUX INTERNAL STANDARD OPERATING PROCEDURES, ORGANISM MISIDENTIFICATION IN ASSOCIATION WITH API MEDIA COULD RESULT FROM A DELAY IN THE APPROPRIATE DIAGNOSIS OR THERAPY, OR RESULT FROM CONTINUED ADMINISTRATION OF INAPPROPRIATE ANTIMICROBIALS OR OTHER POTENTIALLY TOXIC THERAPIES, DUE TO A DELAY IN DETERMIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16312926 ↗
• MalfunctionJan 20, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INDUSTRY CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION RESULT IN ASSOCIATION WITH THE API® LISTERIA 10 STRIPS +10MEDIA (REF. 10300, LOT 1008988000). THE CUSTOMER STATED LOT 1008988000 DID NOT IDENTIFY THE INDUSTRY STRAIN. THE ISOLATE WAS ALSO TESTED ON THE VITEK® 2 WHICH IDENTIFIED THE STRAIN AS LISTERIA MONOCYTOGENES. BIOMÉRIEUX CUSTOMER SERVICE REVIEWED THE PROVIDED LAB REPORTS AND OBSERVED NON-REACTIVE/LOW REACTIVITY ON THE SUGAR WELLS. THE CUSTOMER THEN TESTED THE ATCC® L. MONOCYTOGENES ISOLATE WITH LOTS 1008988000, 1008506770, AND 1008452670 INCUBATED IN TWO SEPARATE INCUBATORS AT 35°C AND 37°C. THE SAME "NO IDENTIFICATION" RESULTS WERE OBTAINED. REFER TO 9615754-2021-00301 AND 9615754-2022-00005 FOR LOTS 1008452670 AND 1008506770, RESPECTIVELY. AS THERE IS NO PATIENT ASSOCIATED WITH THESE INDUSTRY AND QUALITY CONTROL STRAINS, THERE IS NO ADVERSE IMPACT TO ANY PATIENT¿S STATE OF HEALTH. BIOMÉRIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13308113 ↗
• MalfunctionJan 10, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  INTENDED USE: API® LISTERIA IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE IDENTIFICATION OF LISTERIA. IT USES MINIATURIZED TESTS AS WELL AS A SPECIALLY ADAPTED DATABASE. ISSUE DESCRIPTION: AN INDUSTRY CUSTOMER IN SINGAPORE NOTIFIED BIOMERIEUX OF OBTAINING "NO IDENTIFICATION" AND "MISIDENTIFICATION" RESULTS IN ASSOCIATION WITH THE API® LISTERIA TEST (REF. (B)(4), LOT 1008506770). THE CUSTOMER STATED LOT 1008506770 DID NOT IDENTIFY THE INDUSTRY STRAIN. THE ISOLATE WAS ALSO TESTED ON THE VITEK® 2 WHICH IDENTIFIED THE STRAIN AS LISTERIA MONOCYTOGENES. BIOMERIEUX CUSTOMER SERVICE REVIEWED THE PROVIDED LAB REPORTS AND OBSERVED NON-REACTIVE/LOW REACTIVITY ON THE SUGAR WELLS. THE CUSTOMER THEN TESTED THE ATCC® L. MONOCYTOGENES ISOLATE WITH LOTS1008506770, 1008452670 AND 1008988000 INCUBATED IN TWO SEPARATE INCUBATORS AT 35°C AND 37°C. THE SAME "NO IDENTIFICATION" RESULTS WERE OBTAINED. REFER TO (B)(4) AND (B)(4) FOR THE OTHER LOTS. AS THERE ARE NO PATIENTS ASSOCIATED WITH THESE INDUSTRY AND QUALITY CONTROL STRAINS, THERE IS NO ADVERSE IMPACT TO ANY PATIENT¿S STATE OF HEALTH. BIOMERIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13211971 ↗
• MalfunctionDec 29, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) REPORTED A MISIDENTIFICATION OF L. MONOCYTOGENES WHILE USING API® LISTERIA (LOT 1008452670, EXPIRY DATE 23-NOV-2021). A POSITIVE ATCC CULTURE OF L. MONOCYTOGENES AND ONE OF BIOMÉRIEUX SAMPLES (32/1905) WERE TESTED, BUT THE RESULTS FOR BOTH TURNED OUT ABNORMAL (E.G. ESC TEST NOT VERY BLACK, A-MAN TEST NOT YELLOW). FOUR (4) TESTS WERE CONDUCTED INCLUSIVE OF REPEATS BUT THE RESULTS REMAINED THE SAME. SUBSEQUENTLY, THE SAMPLE ID WAS PERFORMED ON THE VITEK® GP ID TEST KIT WHICH IDENTIFIED IT AS L. MONOCYTOGENES. IT HAS BEEN REPORTED THAT THE STRIPS WERE STORED AT THE RECOMMENDED TEMPERATURE AND THERE WERE NO OBSERVATION OF THE BAGS BEING OPENED BEFORE USE. BIOMERIEUX ASSESSED HISTORICAL COMPLAINT RECORDS; THERE IS NO OTHER COMPLAINT REGISTERED FOR THIS BATCH WHICH IS NOW EXPIRED. THERE IS NO ADVERSE TREND REGARDING SUCH ISSUE ON THIS PRODUCT. NO OTHER COMPLAINT FOR THE SAME ISSUE WAS REGISTERED IN 2021: THIS ISSUE SEEMS TO BE ISOLATED. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX HAS OPENED AN INTERNAL INVESTIGATION FOR THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13111255 ↗
• MalfunctionSep 10, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  INTENDED USE: API® LISTERIA IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE IDENTIFICATION OF LISTERIA. 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. INCIDENT DESCRIPTION: A CUSTOMER IN (B)(6) REPORTED TO BIOMÉRIEUX DISCORDANT RESULTS (POTENTIAL MISIDENTIFICATION) IN ASSOCIATION WITH THE PRODUCT API LISTERIA 10STRIPS+10MEDIA (REF 10300, BATCH 1008392040, EXPIRY DATE 15-OCT-2021) WITH AN EXTERNAL QUALITY ASSESSMENT (EQA) SAMPLE. THE CUSTOMER HAS TESTED AN ATCC STRAIN (ATCC REFERENCE NOT REPORTED) WITH MINI-VIDAS, WITH API LISTERIA AS CONFIRMATION METHOD AND ANOTHER METHOD FOR IDENTIFICATION (METHOD AND RESULTS NOT REPORTED): HE REPORTED THAT HE OBTAINED DISCREPANT RESULTS. IT IS SUSPECTED THAT THERE WAS AN USER ERROR REGARDING THE ZYM B (REAGENT USED FOR TEST READING AND INTERPRETATION): IT WAS REPORTED THAT THEY USED ZYM B, 46 AND 64 DAYS AFTER OPENING FOR SOME STRIPS, WHEREA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457290 ↗
• MalfunctionAug 26, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  INTENDED USE: API® LISTERIA IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE IDENTIFICATION OF LISTERIA. 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 ARE POSSIBLE TO IDENTIFY WITH THIS SYSTEM IS GIVEN IN THE TECHNICAL BROCHURE - INFORMATION FOR IDENTIFICATION SOFTWARE. DESCRIPTION OF THE ISSUE: A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING CONFIRMATION DIFFICULTIES FOR LISTERIA SPP. WHEN USING THE API LISTERIA STRIPS (REFERENCE 10300; LOT #1008506770; EXPIRATION DATE : 21/12/2021). THE CUSTOMER HAS PERFORMED THE ALOA® ONE DAY METHOD (A SHORT PROTOCOL FOR THE DETECTION OF L. MONOCYTOGENES AND LISTERIA SPP USING ALOA® MEDIUM) AS WELL AS A CONFIRMATION TEST ON PALCAM MEDIA (RECOMMENDED FOR THE SELECTIVE ISOLATION OF LISTERIA IN FOODSTUFFS) TO DETECT LISTERIA SPP. SUMMARY : TWO (2) WIPES SAMPLES, PROTOCOL CHECKED NOTHING TO REPORT. - SAMPLE 1: ALOA 48H OF INCUBATION, FROM FRASER TUBE FOLLOWING RE-ISOLATION > CHARACTERISTIC COLONIES. - SAMPLE 2: ALOA 48H OF INCUBATION, FROM FRASER TUBE AFTER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12374826 ↗
• MalfunctionJun 14, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  INTENDED USE: API® LISTERIA IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE IDENTIFICATION OF LISTERIA. 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 ORGANISMS THAT IT IS POSSIBLE TO IDENTIFY WITH THIS SYSTEM IS GIVEN IN THE ASSOCIATED TECHNICAL BROCHURE - INFORMATION FOR IDENTIFICATION SOFTWARE. INCIDENT DESCRIPTION: ON THE (B)(6) 2021, A CUSTOMER IN (B)(6) REPORTED TO BIOMÉRIEUX A POTENTIAL MISIDENTIFICATION WITH THE PRODUCT API LISTERIA (REF 10300, BATCH 1008506770, EXPIRY DATE 21-DEC-2021) WITH AN EXTERNAL QUALITY ASSESSMENT (EQA) SAMPLE. THE CUSTOMER TESTED AN EQA SAMPLE, 20A ROUND MA191, FROM LGC AND HAS REPORTED AN ISSUE WITH THE CONFIRMATION PART OF THE TEST. A CONFIRMATION USING API LISTERIA WAS PERFORMED AND FOR ALL ANALYSTS, THE RESULT WAS VERY GOOD IDENTIFICATION OF LISTERIA GRAYI 99.8%. BASED ON THE REPORT FROM LGC: THIS SAMPLE CONTAINED A ¿-HAEMOLYTIC STRAIN OF LISTERIA INNOCUA; 46.7% OF PARTICIPANTS INCORRECTLY REPORTED THE PRESENCE OF LISTERIA MONOCYTOGENES. THIS STRAIN WAS OBTAINED FOR USE IN THE MA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11995421 ↗
• MalfunctionJan 26, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF LISTERIA MONOCYTOGENES AS LISTERIA WELSHIMERI WHEN TESTING AN EXTERNAL QUALITY CONTROL STRAIN WITH API® LISTERIA STRIPS (REF. 10300, LOT 1008288190). THE CUSTOMER STATED THAT HE REPEATED THE TESTING WITH THE SAME SAMPLE AND WITH ANOTHER SAMPLE, AND STILL OBTAINED THE SAME MISIDENTIFICATION. A LISTERIA MONOCYTOGENES MUST BE NEGATIVE FOR THE TESTS DIM / XYL AND TAG, BUT THE CUSTOMER OBTAINED POSITIVE RESULTS WHICH LED TO THE IDENTIFICATION AS L. WELSHIMERII. THERE IS NO PATIENT ASSOCIATED WITH THIS EXTERNAL SURVEY ISOLATE. THEREFORE, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 11230909 ↗
• MalfunctionNov 25, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INDUSTRY CUSTOMER IN CANADA NOTIFIED BIOMÉRIEUX OF A QUALITY CONTROL FAILURE IN ASSOCIATION WITH API® LISTERIA 10STRIPS+10MEDIA (REF. 10300, LOT 1007942830) WHEN TESTING LISTERIA INNOCUA ATCC® 33090¿. LOT 1007942830 MISIDENTIFIED LISTERIA INNOCUA ATCC 33090 STRAIN AS LISTERIA MONOCYTOGENES SPECIES BECAUSE OF A NEGATIVE DIM REACTION. OTHER ATCC® STRAINS BELOW WERE TESTED ON THE IMPACTED LOT AND OBTAINED THE CORRECT RESULTS: LISTERIA MONOCYTOGENES ATCC ®7644¿. LISTERIA IVANOVI ATCC® 19119¿. LISTERIA GRAYI ATCC® 25401¿. BIOMERIEUX CUSTOMER SERVICE HAS REQUESTED THE CUSTOMER TO RETEST LISTERIA INNOCUA ATCC® 33090¿ON ANOTHER LOT OF API STRIPS. RESULTS OF REPEAT TESTING HAVE NOT YET BEEN PROVIDED. 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 WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Patient Involvement

  MAUDE report 10901450 ↗
• MalfunctionAug 12, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATIONS OF LISTERIA MONOCYTOGENES WHEN TESTING TWO (2) STRAINS WITH API® LISTERIA 10STRIPS+10MEDIA (REF 10300, LOT 1007942830). THE LISTERIA MONOCYTOGENES STRAINS INCLUDED ONE (1) ISOLATED FROM FOOD SAMPLES AND ONE (1) INTERNAL L. MONOCYTOGENES QC STRAIN (ATCC® 13932¿). API OBTAINED LISTERIA WELSHIMERI AND LISTERIA INNOCUA AS SIGNIFICANT TAXON FOR THE STRAIN ISOLATED FROM FOOD SAMPLES AND LISTERIA WELSHIMERI AS SIGNIFICANT TAXON FOR THE QC STRAIN. THE EXPECTED IDENTIFICATION OF LISTERIA MONOCYTOGENES WAS CONFIRMED BY A REFERENCE LAB WITH PCR AND SERO-TYPE IDENTIFICATION. THERE IS NO PATIENT INVOLVED AS FOOD AND QC STRAINS ARE IMPACTED. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 10398218 ↗
• MalfunctionMar 26, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN INDUSTRY CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF THE MISIDENTIFICATION OF LISTERIA MONOCYTOGENES AS LISTERIA WELSHIMERI IN ASSOCIATION WITH THE API® LISTERIA 10STRIPS+10MEDIA (REF. 10300, LOT 1007599020). THE CUSTOMER INITIALLY CULTURED THE ISOLATE USING TSAYE AND BLOOD AGAR; AN ISOLATE FROM THE TSAYE AGAR WAS USED FOR IDENTIFICATION TESTING ON THE API ®LISTERIA STRIP. THE API LISTERIA STRIP IDENTIFIED THE ISOLATE AS LISTERIA WELSHIMERI, A NON-HEMOLYTIC ORGANISM. THE CUSTOMER OBSERVED BETA HEMOLYSIS ON THE BLOOD AGAR PLATE; THIS RESULT CONTRADICTED THE LISTERIA WELSHIMERI IDENTIFICATION PROVIDED BY THE API LISTERIA STRIP. BIOMÉRIEUX CUSTOMER SERVICE ADVISED THE CUSTOMER TO TEST THE ISOLATE CULTURED FROM BLOOD AGAR AND TO ALSO TEST REFERENCE SAMPLE ATCC® 15313 LISTERIA MONOCYTOGENES. THE CUSTOMER REPEATED THIS TEST A TOTAL OF THREE (3) TIMES, EACH TIME THE CUSTOMER SAMPLE WAS IDENTIFIED AS LISTERIA WELSHIMERI AND THE REFERENCE SAMPLE OBTAINED THE CORRECT IDENTIFICATION OF LISTERIA MONOCYTOGENES. THE ISOLATE WAS SENT OUT FOR IDENTIFICATION SEQUENCING AND WAS IDENTIFIED AS LISTERIA MONOCYTOGENES. AS THERE IS NO PATIENT ASSOCIATED WITH THIS INDUSTRY SAMPLE, THERE IS NO ADVERSE EVE

  Patient problems: No Patient Involvement

  MAUDE report 9885484 ↗