{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-05", "results": { "skip": 0, "limit": 1, "total": 534 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "9615755-2020-00012", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200813", "manufacturer_address_2": "", "pma_pmn_number": "C1 EXEMPT", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "FOREIGN", "HEALTH PROFESSIONAL", "U" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "MX", "manufacturer_contact_area_code": "", "date_added": "20200813", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "868419", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200813", "brand_name": "CHROMID CANDIDA AGAR", "generic_name": "CHROMID® CANDIDA AGAR", "manufacturer_d_name": "BIOMERIEUX S.A.", "manufacturer_d_address_1": "5 RUE DES AQUEDUCS", "manufacturer_d_address_2": "", "manufacturer_d_city": "CRAPONNE", "manufacturer_d_state": "", "manufacturer_d_zip_code": "69290", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "FR", "manufacturer_d_postal_code": "69290", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20200721", "model_number": "", "catalog_number": "43631", "lot_number": "1008005050", "other_id_number": "", "device_availability": "No", "device_report_product_code": "JSJ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "03573026118969", "udi_public": "03573026118969", "openfda": { "device_name": "Culture Media, Selective And Non-Differential", "medical_specialty_description": "Microbiology", "regulation_number": "866.2360", "device_class": "1" } } ], "product_problems": [ "Incorrect, Inadequate or Imprecise Result or Readings", "Incorrect, Inadequate or Imprecise Result or Readings" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/24/2020", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250801", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200813", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Patient Involvement", "No Patient Involvement" ] } ], "distributor_city": "", "date_report": "20201021", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10403605", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200714", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "204009004", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING FAINT COLOR WHEN PERFORMING QUALITY CONTROL TESTING WITH ATCC® STRAINS ON CHROMID CANDIDA 20 PLATES (REF (B)(4), LOT 1008005050). THE CUSTOMER REPORTED THAT THEY OBSERVED SLIGHTLY BLUE (ALMOST WHITE) COLONIES WHEN GROWING A CANDIDA ALBICANS ATCC STRAIN INSTEAD OF BLUE. THEY ALSO OBSERVED WHITE COLONIES WHEN GROWING A CANDIDA TROPICALIS ATCC STRAIN WHILE THEY SHOULD APPEAR PINK. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS LOT WAS USED BY THIS CUSTOMER TO TEST PATIENT SAMPLES. THE COMPLAINT ONLY INDICATES THAT TESTING WAS PERFORMED WITH ATCC STRAINS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED." }, { "mdr_text_key": "315449822", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A CUSTOMER IN MEXICO NOTIFIED BIOMÉRIEUX OF OBTAINING FAINT COLOR WHEN PERFORMING QUALITY CONTROL TESTING WITH ATCC® STRAINS ON CHROMID CANDIDA 20 PLATES (REF 43631, LOT 1008005050). THE CUSTOMER ALSO OBSERVED WHITE COLONIES WHEN GROWING A CANDIDA TROPICALIS ATCC STRAIN; THE EXPECTED COLONY COLOR WAS PINK. IN RESPONSE TO THE CUSTOMER COMPLAINT, BIOMÉRIEUX CONDUCTED AN INTERNAL INVESTIGATION. LOT 1008005050 HAD ALREADY EXPIRED AT THE TIME OF THE INVESTIGATION, THEREFORE INVESTIGATIONAL TESTING COULD NOT BE PERFORMED. REVIEW OF LOT 1008005050 MANUFACTURING RECORDS FOUND NO ANOMALIES DURING THE MANUFACTURING OF LOT 1008005050. REVIEW OF QUALITY CONTROL TESTS SHOWED LOT 1008005050 MET SPECIFICATION FOR ALL QUALITY CONTROLS TESTED. THIS INCLUDED MEETING SPECIFICATION FOR GROWTH AND CHARACTERISTIC COLONY COLOR WHEN CULTURING ATCC® 10231¿ CANDIDA ALBICANS, ATCC® 9968¿ CANDIDA TROPICALIS, AND ATCC® 1162¿ CANDIDA KEFYR AFTER TWENTY FOUR (24) AND FORTY EIGHT (48) HOURS OF INCUBATION. THE INVESTIGATION ALSO NOTED THE CHROMID CANDIDA 20 PLATES PACKAGE INSERT STATES THE PRODUCT MUST NOT BE EXPOSED TO LIGHT OTHER THAN DURING THE INOCULATION AND READING STEPS. IF THE INSTRUCTIONS FOR USE ARE NOT COMPLIED WITH (EXPOSURE TO LIGHT), A LACK OF COLOR FOR YEAST COLONIES, OR EVEN INHIBITED GROWTH OF CERTAIN STRAINS MAY BE OBSERVED. REFER TO SECTION H10." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "10/21/2020" } ] }