CHROMID® S. aureus Elite agarRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03573026600440), received between Sep 19, 2017 and Jul 5, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 5, 2024False Negative Result; False Negative Result

  INTENDED USE: CHROMOGENIC MEDIUM FOR THE SELECTIVE ISOLATION AND THE DIRECT IDENTIFICATION OF S. AUREUS. THIS CHROMOGENIC MEDIUM IS INTENDED FOR THE SELECTIVE ISOLATION AND THE DIRECT IDENTIFICATION OF S. AUREUS IN HUMAN SPECIMENS: IN 18 TO 24 HOURS FOR THE FOLLOWING SPECIMENS: BLOOD CULTURES, NASAL SWABS, SUPPURATIONS, EAR/NOSE/THROAT SAMPLES, GENITAL SAMPLES, STOOL SAMPLES, SKIN SAMPLES FROM SERIOUS BURN VICTIMS, RESPIRATORY SAMPLES (INCLUDING RESPIRATORY SAMPLES FROM PATIENTS WITH CYSTIC FIBROSIS), AND UP TO 48 TO 72 HOURS FOR RESPIRATORY SAMPLES FROM PATIENTS WITH CYSTIC FIBROSIS. THIS MEDIUM IS INTENDED FOR THE PREVENTION AND DIAGNOSIS OF S. AUREUS INFECTIONS USING SAMPLES OF HUMAN ORIGIN. ISSUE DESCRIPTION: A CUSTOMER IN BELGIUM NOTIFIED BIOMÉRIEUX OF POTENTIAL FALSE NEGATIVE RESULTS (NO CHARACTERISTIC COLOR) FOR STAPHYLOCOCCUS AUREUS PATIENT STRAINS AND FOR ATCC 29213 STRAINS IN ASSOCIATION WITH CHROMID S.AUREUS ELITE 20 PL (REFERENCE (B)(4) LOT 1010676710, EXPIRATION DATE 20-AUG-2024). IT WAS REPORTED THAT THE CUSTOMER PERFORMED A QUALITY CONTROL TEST WITH ATCC 29213 AND OBTAINED YELLOW COLONIES INSTEAD OF PINK COLONIES WITH PLATES FROM LOT 1010676710. IT WAS REPORTED THAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19678232 ↗
• MalfunctionJun 27, 2024False Positive Result; False Positive Result

  INTENDED USE: CHROMOGENIC MEDIUM FOR THE SELECTIVE ISOLATION AND THE DIRECT IDENTIFICATION OF S. AUREUS. THIS CHROMOGENIC MEDIUM IS INTENDED FOR THE SELECTIVE ISOLATION AND THE DIRECT IDENTIFICATION OF S. AUREUS IN HUMAN SPECIMENS: IN 18 TO 24 HOURS FOR THE FOLLOWING SPECIMENS: BLOOD CULTURES, NASAL SWABS, SUPPURATIONS, EAR/NOSE/THROAT SAMPLES, GENITAL SAMPLES, STOOL SAMPLES, SKIN SAMPLES FROM SERIOUS BURN VICTIMS, RESPIRATORY SAMPLES (INCLUDING RESPIRATORY SAMPLES FROM PATIENTS WITH CYSTIC FIBROSIS), AND UP TO 48 TO 72 HOURS FOR RESPIRATORY SAMPLES FROM PATIENTS WITH CYSTIC FIBROSIS. THIS MEDIUM IS INTENDED FOR THE PREVENTION AND DIAGNOSIS OF S. AUREUS INFECTIONS USING SAMPLES OF HUMAN ORIGIN. ISSUE DESCRIPTION: A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX THAT THEY OBTAINED FALSE POSITIVE RESULTS FOR MULTIPLE ISOLATES IN ASSOCIATION WITH THE CHROMID S.AUREUS ELITE 20 PL (REF (B)(4) , LOT 1010643790). THE CUSTOMER REPORTED THAT OUT OF 17 PLATES THAT SHOWED POSITIVE FOR STAPHYLOCOCCUS AUREUS (PINK COLONIES), 3 WERE CONFIRMED TO BE S. AUREUS AND 14 WERE CONFIRMED TO BE S. EPIDERMIDIS. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO OR CONTRIBUTED TO DEATH, SERI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19623280 ↗
• MalfunctionJun 25, 2024False Negative Result; False Negative Result

  INTENDED USE: CHROMOGENIC MEDIUM FOR THE SELECTIVE ISOLATION AND THE DIRECT IDENTIFICATION OF S. AUREUS. THIS CHROMOGENIC MEDIUM IS INTENDED FOR THE SELECTIVE ISOLATION AND THE DIRECT IDENTIFICATION OF S. AUREUS IN HUMAN SPECIMENS: ¿ IN 18 TO 24 HOURS FOR THE FOLLOWING SPECIMENS: BLOOD CULTURES, NASAL SWABS, SUPPURATIONS, EAR/NOSE/THROAT SAMPLES, GENITAL SAMPLES, STOOL SAMPLES, SKIN SAMPLES FROM SERIOUS BURN VICTIMS, RESPIRATORY SAMPLES (INCLUDING RESPIRATORY SAMPLES FROM PATIENTS WITH CYSTIC FIBROSIS), ¿ AND UP TO 48 TO 72 HOURS FOR RESPIRATORY SAMPLES FROM PATIENTS WITH CYSTIC FIBROSIS. THIS MEDIUM IS INTENDED FOR THE PREVENTION AND DIAGNOSIS OF S. AUREUS INFECTIONS USING SAMPLES OF HUMAN ORIGIN. ISSUE DESCRIPTION: A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE RESULT (NO CHARACTERISTIC COLOR) IN ASSOCIATION WITH CHROMID S. AUREUS ELITE 20 PL (REF. (B)(4), LOT 1010624600, AND EXPIRATION DATE 21-JUL-2024). IT WAS REPORTED THAT ON TWO SPUTUM SAMPLES, THE STAPHYLOCOCCUS AUREUS STRAINS DID NOT STAIN ON CHROMID S. AUREUS ELITE, BATCH 1010624600. THE CUSTOMER MADE A COMPARISON WITH ANOTHER BATCH, AND THE STRAINS DID HAVE PINK COLORATION. ADDITIONAL INFORMATION HAS BEEN REQU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19603043 ↗
• MalfunctionMay 7, 2024False Negative Result; False Negative Result

  INTENDED USE: CHROMOGENIC MEDIUM FOR THE SELECTIVE ISOLATION AND THE DIRECT IDENTIFICATION OF S. AUREUS. THIS CHROMOGENIC MEDIUM IS INTENDED FOR THE SELECTIVE ISOLATION AND THE DIRECT IDENTIFICATION OF S. AUREUS IN HUMAN SPECIMENS: IN 18 TO 24 HOURS FOR THE FOLLOWING SPECIMENS: BLOOD CULTURES, NASAL SWABS, SUPPURATIONS, EAR/NOSE/THROAT SAMPLES, GENITAL SAMPLES, STOOL SAMPLES, SKIN SAMPLES FROM SERIOUS BURN VICTIMS, RESPIRATORY SAMPLES (INCLUDING RESPIRATORY SAMPLES FROM PATIENTS WITH CYSTIC FIBROSIS), AND UP TO 48 TO 72 HOURS FOR RESPIRATORY SAMPLES FROM PATIENTS WITH CYSTIC FIBROSIS. THIS MEDIUM IS INTENDED FOR THE PREVENTION AND DIAGNOSIS OF S. AUREUS INFECTIONS USING SAMPLES OF HUMAN ORIGIN. ISSUE DESCRIPTION: A CUSTOMER IN AUSTRALIA NOTIFIED BIOMÉRIEUX THAT THEY OBTAINED FALSE NEGATIVE RESULTS FOR STAPHYLOCOCCUS AUREUS IN AND POSSIBLE FALSE POSITIVE RESULTS FOR SERRATIA MARCESCENS IN ASSOCIATION WITH THE CHROMID S.AUREUS ELITE 20 PL (REF 419042, LOT 1010407570). THE CUSTOMER REPORTED THAT THEY OBSERVED PINK COLONY COLORATION FOR SERRATIA MARCESCENS AND YELLOW COLORATION FOR STAPHYLOCOCCUS AUREUS AFTER 48 HOURS OF INCUBATION. IDENTIFICATIONS OF THE COLONIES WERE PERFORMED WITH M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19264355 ↗
• MalfunctionNov 9, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PRODUCT INTENDED USE : CHROMID¿ S. AUREUS ELITE AGAR IS A CHROMOGENIC MEDIUM FOR THE SELECTIVE ISOLATION AND THE DIRECT IDENTIFICATION OF S. AUREUS IN HUMAN SPECIMENS THIS MEDIUM IS INTENDED FOR THE PREVENTION AND DIAGNOSIS OF S. AUREUS INFECTIONS USING SAMPLES OF HUMAN ORIGIN. DESCRIPTION OF THE ISSUE: ON 14OCT2020, A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING ATYPICAL COLOR COLONY GROWTH WHEN TESTING (B)(6) PATIENT STRAINS WITH CHROMID® S. AUREUS ELITE 20 PL (REF. 419042; LOT 1008162330). THE CUSTOMER REPORTED THAT HE OBSERVED WHITE OR YELLOW COLONIES WHEN TESTING THREE SPECIMENS FROM SKIN ABSCESSES FOR THREE DIFFERENT PATIENTS. THE CUSTOMER USED MASS SPECTROMETRY TO IDENTIFY THE ORGANISM AND OBTAINED A (B)(6) RESULT FOR ALL THREE PATIENTS. ACCORDING TO THE PRODUCT INSTRUCTIONS FOR USE, S. AUREUS COLONIES ARE EXPECTED TO BE PINK TO LIGHT PINK; NOT WHITE OR YELLOW. THE CUSTOMER REPORTED THAT NO INCORRECT RESULTS WERE REPORTED. THERE IS NO INDICATION FROM THE CUSTOMER THAT THIS EVENT LED TO A DELAY OF RESULT OR IMPACTED THE PATIENT STATE OF HEALTH. THIS MDR IS INITIATED FOR PATIENT THREE. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10814046 ↗
• MalfunctionNov 9, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PRODUCT INTENDED USE : CHROMID¿ S. AUREUS ELITE AGAR IS A CHROMOGENIC MEDIUM FOR THE SELECTIVE ISOLATION AND THE DIRECT IDENTIFICATION OF S. AUREUS IN HUMAN SPECIMENS THIS MEDIUM IS INTENDED FOR THE PREVENTION AND DIAGNOSIS OF S. AUREUS INFECTIONS USING SAMPLES OF HUMAN ORIGIN. DESCRIPTION OF THE ISSUE: ON 14OCT2020, A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING ATYPICAL COLOR COLONY GROWTH WHEN TESTING STAPHYLOCOCCUS AUREUS PATIENT STRAINS WITH CHROMID® S.AUREUS ELITE 20 PL (REF. 419042; LOT 1008162330). THE CUSTOMER REPORTED THAT HE OBSERVED WHITE OR YELLOW COLONIES WHEN TESTING THREE SPECIMENS FROM SKIN ABSCESSES FOR THREE DIFFERENT PATIENTS. THE CUSTOMER USED MASS SPECTROMETRY TO IDENTIFY THE ORGANISM AND OBTAINED A STAPHYLOCOCCUS AUREUS RESULT FOR ALL THREE PATIENTS. ACCORDING TO THE PRODUCT INSTRUCTIONS FOR USE, S. AUREUS COLONIES ARE EXPECTED TO BE PINK TO LIGHT PINK; NOT WHITE OR YELLOW. THE CUSTOMER REPORTED THAT NO INCORRECT RESULTS WERE REPORTED. THERE IS NO INDICATION FROM THE CUSTOMER THAT THIS EVENT LED TO A DELAY OF RESULT OR IMPACTED THE PATIENT STATE OF HEALTH. THIS MDR IS FOR PATIENT ONE. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10814035 ↗
• MalfunctionNov 9, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PRODUCT INTENDED USE : CHROMID¿ S. AUREUS ELITE AGAR IS A CHROMOGENIC MEDIUM FOR THE SELECTIVE ISOLATION AND THE DIRECT IDENTIFICATION OF S. AUREUS IN HUMAN SPECIMENS THIS MEDIUM IS INTENDED FOR THE PREVENTION AND DIAGNOSIS OF S. AUREUS INFECTIONS USING SAMPLES OF HUMAN ORIGIN. DESCRIPTION OF THE ISSUE: ON (B)(6) 2020, A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING ATYPICAL COLOR COLONY GROWTH WHEN TESTING STAPHYLOCOCCUS AUREUS PATIENT STRAINS WITH CHROMID® S.AUREUS ELITE 20 PL (REF. 419042; LOT 1008162330). THE CUSTOMER REPORTED THAT HE OBSERVED WHITE OR YELLOW COLONIES WHEN TESTING THREE SPECIMENS FROM SKIN ABSCESSES FOR THREE DIFFERENT PATIENTS. THE CUSTOMER USED MASS SPECTROMETRY TO IDENTIFY THE ORGANISM AND OBTAINED A STAPHYLOCOCCUS AUREUS RESULT FOR ALL THREE PATIENTS. ACCORDING TO THE PRODUCT INSTRUCTIONS FOR USE, S. AUREUS COLONIES ARE EXPECTED TO BE PINK TO LIGHT PINK; NOT WHITE OR YELLOW. THE CUSTOMER REPORTED THAT NO INCORRECT RESULTS WERE REPORTED. THERE IS NO INDICATION FROM THE CUSTOMER THAT THIS EVENT LED TO A DELAY OF RESULT OR IMPACTED THE PATIENT STATE OF HEALTH. THIS MDR IS FOR PATIENT TWO. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10814015 ↗
• MalfunctionMay 6, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 16-APR-2020, A (B)(6) CUSTOMER REPORTED ABSENCE OF TYPICAL PINK COLORATION WHEN GROWING S. AUREUS STRAINS WITH CHROMID S.AUREUS ELITE 20 PL, REFERENCE 419042, LOT 1007883410, EXPIRY DATE 29-MAY-2020. THE CUSTOMER REPORTED THAT TYPICAL PINK COLORED COLONIES FOR A S. AUREUS PATIENT STRAIN WERE NOT OBSERVED AS EXPECTED. THE SAME STRAIN SHOWED PINK COLONIES ON A LOT NUMBER PREVIOUSLY USED BY THE CUSTOMER. THE CUSTOMER SUBSEQUENTLY SUBCULTURED THE SAME S. AUREUS PATIENT STRAIN ON TWO DIFFERENT LOT NUMBERS OF REFERENCE 419042 AND ON BLOOD AGAR IN PARALLEL. ON LOT 1007883410, COLONIES ARE BEIGE-YELLOW AND ON A DIFFERENT LOT NUMBER, COLONIES ARE PINK-PURPLE AS EXPECTED FOR S.AUREUS. THE CUSTOMER ALSO OBSERVED THIS ISSUE ON OTHERS SAMPLES (BLOOD CULTURES OR ORTHOPEDIC WOUND SAMPLES). THERE IS NO INDICATION FROM THE CUSTOMER THAT THIS EVENT IMPACTED THE PATIENT STATE OF HEALTH OR LED TO A DELAY OF RESULTS. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10028243 ↗
• MalfunctionSep 19, 2017False Negative Result; Incorrect Or Inadequate Test Results; False Negative Result; Incorrect Or Inadequate Test Results

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FAILURE TO IDENTIFY STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH CHROMID® S. AUREUS ELITE (REF 419042), LOT 1005778360. THE CUSTOMER REPORTED THAT THEY HAD INOCULATED A NASAL SWAB DIRECTLY ON THE AGAR PLATE. AFTER 18-24 HOURS OF INCUBATION, THE CUSTOMER OBSERVED BACTERIAL GROWTH OF YELLOW COLONIES, NON-CHARACTERISTIC FOR STAPHYLOCOCCUS AUREUS. USING THE MALDI-TOF TESTING METHOD, THE CUSTOMER IDENTIFIED THE ORGANISM STAPHYLOCOCCUS AUREUS. THE CUSTOMER STATED THAT THERE WERE NO PATIENT RESULTS AFFECTED, NO WRONG RESULTS REPORTED TO A PHYSICIAN, NO INCORRECT TREATMENT GIVEN, NO PATIENT HARM, AND NO DELAY IN REPORTING PATIENT RESULTS. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6875454 ↗