{ "code": "LON", "deviceName": "System, Test, Automated, Antimicrobial Susceptibility, Short Incubation", "deviceClass": "II", "regulationNumber": "866.1645", "panel": "Microbiology", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 289, "last12Months": 3 }, "adverseEvents": { "total": 1577, "last12Months": 671 }, "reviewDays": { "median": 58, "sampleSize": 289 }, "recalls": { "total": 237, "recent": [ { "resNumber": "Z-2888-2026", "status": "Open, Classified", "recallClass": null, "firm": "Beckman Coulter, Inc.", "firmAsPublished": "Beckman Coulter Inc.", "reason": "Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications.\"", "initiated": "2026-06-26" }, { "resNumber": "Z-2889-2026", "status": "Open, Classified", "recallClass": null, "firm": "Beckman Coulter, Inc.", "firmAsPublished": "Beckman Coulter Inc.", "reason": "Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications.\"", "initiated": "2026-06-26" }, { "resNumber": "Z-2715-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "bioMerieux, Inc.", "firmAsPublished": "Biomerieux Inc", "reason": "Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.", "initiated": "2026-06-04" }, { "resNumber": "Z-0239-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Becton, Dickinson and Company", "firmAsPublished": "Becton Dickinson & Co.", "reason": "Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.", "initiated": "2025-09-23" }, { "resNumber": "Z-2671-2025", "status": "Open, Classified", "recallClass": "Class II", "firm": "bioMerieux, Inc.", "firmAsPublished": "bioMerieux, Inc.", "reason": "Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards", "initiated": "2025-06-26" } ] }, "recentClearances": [ { "kNumber": "K260282", "deviceName": "VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance", "applicant": "bioMerieux, Inc.", "company": "bioMerieux, Inc.", "decisionDate": "2026-04-15", "dateReceived": "2026-01-29" }, { "kNumber": "K260281", "deviceName": "VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)", "applicant": "BIOMERIEUX", "company": "bioMerieux, Inc.", "decisionDate": "2026-03-26", "dateReceived": "2026-01-29" }, { "kNumber": "K251579", "deviceName": "VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)", "applicant": "bioMerieux, Inc.", "company": "bioMerieux, Inc.", "decisionDate": "2025-08-21", "dateReceived": "2025-05-23" }, { "kNumber": "K251713", "deviceName": "BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)", "applicant": "Becton, Dickinson and Company", "company": "Becton, Dickinson and Company", "decisionDate": "2025-08-08", "dateReceived": "2025-06-03" }, { "kNumber": "K250447", "deviceName": "BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)", "applicant": "Becton, Dickinson and Company", "company": "Becton, Dickinson and Company", "decisionDate": "2025-05-19", "dateReceived": "2025-02-18" }, { "kNumber": "K234012", "deviceName": "VITEK COMPACT PRO", "applicant": "bioMerieux, Inc.", "company": "bioMerieux, Inc.", "decisionDate": "2025-03-14", "dateReceived": "2023-12-19" }, { "kNumber": "K250344", "deviceName": "BD Phoenix™ Automated Microbiology System", "applicant": "Becton, Dickinson and Company", "company": "Becton, Dickinson and Company", "decisionDate": "2025-03-06", "dateReceived": "2025-02-06" }, { "kNumber": "K233986", "deviceName": "BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL)", "applicant": "Becton, Dickinson and Company", "company": "Becton, Dickinson and Company", "decisionDate": "2024-03-15", "dateReceived": "2023-12-18" }, { "kNumber": "K234000", "deviceName": "VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)", "applicant": "bioMerieux, Inc.", "company": "bioMerieux, Inc.", "decisionDate": "2024-03-11", "dateReceived": "2023-12-18" }, { "kNumber": "K232756", "deviceName": "Colibrí", "applicant": "Copan Wasp Srl", "company": "Copan WASP", "decisionDate": "2023-12-27", "dateReceived": "2023-09-08" } ], "topApplicants": [ { "name": "bioMerieux, Inc.", "count": 113 }, { "name": "Becton, Dickinson & CO", "count": 106 }, { "name": "Dade Behring, Inc.", "count": 37 }, { "name": "Becton, Dickinson and Company", "count": 14 }, { "name": "Bd Diagnostic Systems", "count": 3 } ], "topCompanies": [ { "name": "Becton, Dickinson and Company", "count": 122, "spellings": 4 }, { "name": "bioMerieux, Inc.", "count": 116, "spellings": 4 }, { "name": "Dade Behring, Inc.", "count": 37, "spellings": 1 }, { "name": "BD Diagnostic Systems", "count": 3, "spellings": 1 }, { "name": "Copan WASP", "count": 2, "spellings": 1 } ], "newEntrants": [], "baseline": { "months": [ { "month": "2023-01-01", "observed": 22, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 7, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 30, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 58, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 31, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 48, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 17, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 32, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 16, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 66, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 36, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 25, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 29, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 64, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 12, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 10, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 13, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 18, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 61, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 48, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 36, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 9, "expectedLow": 0, "expectedHigh": 72.12619417113842, "isSufficient": true }, { "month": "2025-02-01", "observed": 49, "expectedLow": 0, "expectedHigh": 53.120259393573804, "isSufficient": true }, { "month": "2025-03-01", "observed": 43, "expectedLow": 0, "expectedHigh": 71.49645329265033, "isSufficient": true }, { "month": "2025-04-01", "observed": 15, "expectedLow": 0, "expectedHigh": 77.42031350487042, "isSufficient": true }, { "month": "2025-05-01", "observed": 12, "expectedLow": 0, "expectedHigh": 67.61335357403617, "isSufficient": true }, { "month": "2025-06-01", "observed": 30, "expectedLow": 0, "expectedHigh": 60.42996252396308, "isSufficient": true }, { "month": "2025-07-01", "observed": 39, "expectedLow": 0, "expectedHigh": 95.97900090734524, "isSufficient": true }, { "month": "2025-08-01", "observed": 295, "expectedLow": 0, "expectedHigh": 69.78176088925142, "isSufficient": true }, { "month": "2025-09-01", "observed": 84, "expectedLow": 0, "expectedHigh": 277.9622198780987, "isSufficient": true }, { "month": "2025-10-01", "observed": 60, "expectedLow": 0, "expectedHigh": 265.739600420615, "isSufficient": true }, { "month": "2025-11-01", "observed": 20, "expectedLow": 0, "expectedHigh": 226.90723783340343, "isSufficient": true }, { "month": "2025-12-01", "observed": 28, "expectedLow": 0, "expectedHigh": 232.11485889751972, "isSufficient": true }, { "month": "2026-01-01", "observed": 18, "expectedLow": 0, "expectedHigh": 253.33695916963333, "isSufficient": true }, { "month": "2026-02-01", "observed": 86, "expectedLow": 0, "expectedHigh": 202.2792283894415, "isSufficient": true }, { "month": "2026-03-01", "observed": 102, "expectedLow": 0, "expectedHigh": 235.86481397657406, "isSufficient": true } ], "sufficientMonths": 15, "method": "ewma_alpha_0.3_sd_2 corpus_adjusted" }, "signal": { "summary": "LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation) has one finding. 4 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2888-2026, Z-2889-2026, Z-2715-2026, Z-0239-2026).", "severity": 75, "factors": [ { "kind": "recall", "detail": "4 recalls opened in the last 12 months and not yet terminated (Class II)", "recordIds": [ "Z-2888-2026", "Z-2889-2026", "Z-2715-2026", "Z-0239-2026" ], "severity": 75 } ], "sourcesChecked": [ "predicate ancestry", "recalls", "adverse events", "new entrants", "review time", "crowding" ] }, "predicatePreview": { "edges": [], "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet." }, "sources": [ { "label": "classification", "url": "https://api.fda.gov/device/classification.json?search=product_code%3ALON" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALON" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALON" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3ALON" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ALON" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ALON" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ALON" } ], "provenance": [ { "dataset": "device/510k", "loadedAt": "2026-08-10T19:40:09Z", "ingestRun": 51, "exportDate": "2026-08-08" }, { "dataset": "device/classification", "loadedAt": "2026-08-10T06:54:18Z", "ingestRun": 2, "exportDate": "2026-08-08" }, { "dataset": "device/enforcement", "loadedAt": "2026-08-10T19:40:12Z", "ingestRun": 53, "exportDate": "2026-08-04" }, { "dataset": "device/event", "loadedAt": "2026-08-11T13:49:57Z", "ingestRun": 73, "exportDate": "2026-08-11" }, { "dataset": "device/recall", "loadedAt": "2026-08-10T19:40:11Z", "ingestRun": 52, "exportDate": "2026-08-08" }, { "dataset": "device/registrationlisting", "loadedAt": "2026-08-10T07:06:24Z", "ingestRun": 10, "exportDate": "2026-08-08" } ], "retrievedAt": "2026-08-11T13:51:45.739Z" }