{ "code": "JSJ", "deviceName": "Culture Media, Selective And Non-Differential", "deviceClass": "I", "regulationNumber": "866.2360", "panel": "Microbiology", "definition": null, "submissionTypeId": "4", "submissionType": "510(k)", "clearances": { "total": 307, "last12Months": 0 }, "adverseEvents": { "total": 411, "last12Months": 75 }, "reviewDays": { "median": 27, "sampleSize": 307 }, "recalls": { "total": 6, "recent": [ { "resNumber": "Z-1474-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Remel, Inc.", "firmAsPublished": "Remel, Inc", "reason": "Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.", "initiated": "2026-02-05" }, { "resNumber": "Z-0284-2019", "status": "Terminated", "recallClass": "Class III", "firm": "Acumedia Manufacturers, Inc.", "firmAsPublished": "Acumedia Manufacturers, Inc.", "reason": "The product is labeled with an incorrect expiration date.", "initiated": "2018-08-02" }, { "resNumber": "Z-1571-2016", "status": "Terminated", "recallClass": "Class II", "firm": "Hardy Diagnostics", "firmAsPublished": "Hardy Diagnostics", "reason": "Performance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GBS) with the target QC organism, Streptococcus agalactiae (ATCC 13813) due to product deterioration.", "initiated": "2016-03-21" }, { "resNumber": "Z-1799-2013", "status": "Terminated", "recallClass": "Class II", "firm": "Becton, Dickinson and Company", "firmAsPublished": "Becton Dickinson & Co.", "reason": "Microbiological identification media may exhibit reduced levels of Vancomycin.", "initiated": "2013-06-06" }, { "resNumber": "Z-1800-2013", "status": "Terminated", "recallClass": "Class II", "firm": "Becton, Dickinson and Company", "firmAsPublished": "Becton Dickinson & Co.", "reason": "Microbiological identification media may exhibit reduced levels of Vancomycin.", "initiated": "2013-06-06" } ] }, "recentClearances": [ { "kNumber": "K882463", "deviceName": "POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421", "applicant": "Lakewood Biochemical Co., Inc.", "company": "Lakewood Biochemical Co., Inc.", "decisionDate": "1988-06-22", "dateReceived": "1988-06-15" }, { "kNumber": "K881578", "deviceName": "STREPTOSEL", "applicant": "Acumedia Manufacturers, Inc.", "company": "Acumedia Manufacturers, Inc.", "decisionDate": "1988-04-18", "dateReceived": "1988-04-11" }, { "kNumber": "K881574", "deviceName": "W-L DIFFERENTIAL MEDIUM", "applicant": "Acumedia Manufacturers, Inc.", "company": "Acumedia Manufacturers, Inc.", "decisionDate": "1988-04-18", "dateReceived": "1988-04-11" }, { "kNumber": "K881573", "deviceName": "PHYTONE YEAST EXTRACT AGAR", "applicant": "Acumedia Manufacturers, Inc.", "company": "Acumedia Manufacturers, Inc.", "decisionDate": "1988-04-18", "dateReceived": "1988-04-11" }, { "kNumber": "K881571", "deviceName": "YM BROTH", "applicant": "Acumedia Manufacturers, Inc.", "company": "Acumedia Manufacturers, Inc.", "decisionDate": "1988-04-18", "dateReceived": "1988-04-11" }, { "kNumber": "K881570", "deviceName": "SABOURAUD MALTOSE AGAR", "applicant": "Acumedia Manufacturers, Inc.", "company": "Acumedia Manufacturers, Inc.", "decisionDate": "1988-04-18", "dateReceived": "1988-04-11" }, { "kNumber": "K881565", "deviceName": "INHIBITORY MOLD AGAR", "applicant": "Acumedia Manufacturers, Inc.", "company": "Acumedia Manufacturers, Inc.", "decisionDate": "1988-04-18", "dateReceived": "1988-04-11" }, { "kNumber": "K881561", "deviceName": "TERGITOL 7 BROTH", "applicant": "Acumedia Manufacturers, Inc.", "company": "Acumedia Manufacturers, Inc.", "decisionDate": "1988-04-18", "dateReceived": "1988-04-11" }, { "kNumber": "K881549", "deviceName": "MYCOLOGICAL AGAR W/LOW PH", "applicant": "Acumedia Manufacturers, Inc.", "company": "Acumedia Manufacturers, Inc.", "decisionDate": "1988-04-18", "dateReceived": "1988-04-08" }, { "kNumber": "K881547", "deviceName": "MITIS SALIVARIUS AGAR", "applicant": "Acumedia Manufacturers, Inc.", "company": "Acumedia Manufacturers, Inc.", "decisionDate": "1988-04-18", "dateReceived": "1988-04-08" } ], "topApplicants": [ { "name": "Acumedia Manufacturers, Inc.", "count": 30 }, { "name": "Lakewood Biochemical Co., Inc.", "count": 30 }, { "name": "Hardy Media", "count": 26 }, { "name": "Otisville Biotech, Inc.", "count": 23 }, { "name": "Gibco Laboratories Life Technologies, Inc.", "count": 18 } ], "topCompanies": [ { "name": "Acumedia Manufacturers, Inc.", "count": 30, "spellings": 1 }, { "name": "Lakewood Biochemical Co., Inc.", "count": 30, "spellings": 1 }, { "name": "Hardy Media Inc Dba Hardy Diag", "count": 26, "spellings": 1 }, { "name": "Otisville Biotech, Inc.", "count": 23, "spellings": 1 }, { "name": "Gibco Laboratories Life Technologies, Inc.", "count": 18, "spellings": 1 } ], "newEntrants": [], "baseline": { "months": [ { "month": "2023-01-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 4, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 5, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-04-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-07-01", "observed": 138, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-08-01", "observed": 187, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-09-01", "observed": 10, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2026-01-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2026-02-01", "observed": 39, "expectedLow": null, "expectedHigh": null, "isSufficient": false } ], "sufficientMonths": 0, "method": null }, "signal": { "summary": "JSJ (Culture Media, Selective And Non-Differential) has one finding. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-1474-2026).", "severity": 75, "factors": [ { "kind": "recall", "detail": "1 recall opened in the last 12 months and not yet terminated (Class II)", "recordIds": [ "Z-1474-2026" ], "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%3AJSJ" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJSJ" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJSJ" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3AJSJ" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AJSJ" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AJSJ" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AJSJ" } ], "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": "2026-08-11T13:51:45.727Z" }