{ "code": "JIX", "deviceName": "Calibrator, Multi-Analyte Mixture", "deviceClass": "II", "regulationNumber": "862.1150", "panel": "Clinical Chemistry", "definition": null, "submissionTypeId": "4", "submissionType": "510(k)", "clearances": { "total": 302, "last12Months": 0 }, "adverseEvents": { "total": 47, "last12Months": 8 }, "reviewDays": { "median": 48, "sampleSize": 302 }, "recalls": { "total": 73, "recent": [ { "resNumber": "Z-2895-2026", "status": "Open, Classified", "recallClass": null, "firm": "Aniara Diagnostica LLC", "firmAsPublished": "Aniara Diagnostica LLC", "reason": "Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.", "initiated": "2026-07-01" }, { "resNumber": "Z-1840-2025", "status": "Open, Classified", "recallClass": "Class II", "firm": "Mckesson Medical-Surgical Inc. Corporate Office", "firmAsPublished": "Mckesson Medical-Surgical Inc. Corporate Office", "reason": "transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.", "initiated": "2025-04-24" }, { "resNumber": "Z-1759-2024", "status": "Open, Classified", "recallClass": "Class II", "firm": "Randox Laboratories, Limited", "firmAsPublished": "Randox Laboratories Ltd.", "reason": "Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.", "initiated": "2024-03-05" }, { "resNumber": "Z-1328-2024", "status": "Open, Classified", "recallClass": "Class II", "firm": "Randox Laboratories, Limited", "firmAsPublished": "Randox Laboratories Ltd.", "reason": "The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.", "initiated": "2024-03-01" }, { "resNumber": "Z-0752-2024", "status": "Open, Classified", "recallClass": "Class II", "firm": "Randox Laboratories, Limited", "firmAsPublished": "Randox Laboratories Ltd.", "reason": "CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.", "initiated": "2023-11-20" } ] }, "recentClearances": [ { "kNumber": "K161140", "deviceName": "VITROS Chemistry Products Calibrator Kit 3", "applicant": "Ortho-Clinical Diagnostics, Inc.", "company": "Ortho-Clinical Diagnostics, Inc.", "decisionDate": "2016-05-20", "dateReceived": "2016-04-22" }, { "kNumber": "K153365", "deviceName": "ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator", "applicant": "Siemens Healthcare Diagnostics, Inc.", "company": "Siemens Healthcare Diagnostics, Inc.", "decisionDate": "2015-12-18", "dateReceived": "2015-11-20" }, { "kNumber": "K151552", "deviceName": "ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II", "applicant": "Elitechgroup", "company": "Elitechgroup, Inc.", "decisionDate": "2015-07-08", "dateReceived": "2015-06-09" }, { "kNumber": "K140790", "deviceName": "Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)", "applicant": "Siemens Healthcare Diagnostics", "company": "Siemens Healthcare Diagnostics, Inc.", "decisionDate": "2015-06-15", "dateReceived": "2014-03-31" }, { "kNumber": "K141388", "deviceName": "SYSTEM CALIBRATER", "applicant": "Beckman Coulter Ireland, Inc.", "company": "Beckman Coulter Ireland, Inc.", "decisionDate": "2014-07-11", "dateReceived": "2014-05-27" }, { "kNumber": "K133330", "deviceName": "C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN", "applicant": "Roche Diagnostics", "company": "Roche Diagnostics Corporation", "decisionDate": "2013-11-26", "dateReceived": "2013-11-01" }, { "kNumber": "K130765", "deviceName": "ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II", "applicant": "Elitechgroup", "company": "Elitechgroup, Inc.", "decisionDate": "2013-04-04", "dateReceived": "2013-03-20" }, { "kNumber": "K123321", "deviceName": "DIMENSION CHEMISTRY III CALIBRATORY", "applicant": "Siemens Healthcare Diagnostics", "company": "Siemens Healthcare Diagnostics, Inc.", "decisionDate": "2013-02-15", "dateReceived": "2012-10-26" }, { "kNumber": "K123372", "deviceName": "ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR", "applicant": "Abbott Laboratories", "company": "Abbott Laboratories, Inc.", "decisionDate": "2013-01-14", "dateReceived": "2012-11-01" }, { "kNumber": "K122398", "deviceName": "RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS", "applicant": "Siemens Healthcare Diagnostics, Inc.", "company": "Siemens Healthcare Diagnostics, Inc.", "decisionDate": "2012-10-12", "dateReceived": "2012-08-07" } ], "topApplicants": [ { "name": "Alko Diagnostic Corp.", "count": 21 }, { "name": "Dade Behring, Inc.", "count": 18 }, { "name": "Bhp Diagnostix, Inc.", "count": 11 }, { "name": "Roche Diagnostics Corp.", "count": 10 }, { "name": "Roche Diagnostic Systems, Inc.", "count": 9 } ], "topCompanies": [ { "name": "Alko Diagnostic Corp.", "count": 21, "spellings": 1 }, { "name": "Dade Behring, Inc.", "count": 18, "spellings": 1 }, { "name": "Roche Diagnostics Corporation", "count": 14, "spellings": 2 }, { "name": "Siemens Healthcare Diagnostics, Inc.", "count": 12, "spellings": 2 }, { "name": "Bhp Diagnostix, Inc.", "count": 11, "spellings": 1 } ], "newEntrants": [], "baseline": { "months": [ { "month": "2023-01-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 4, "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": "2024-07-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-02-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-04-01", "observed": 5, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-06-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-07-01", "observed": 4, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-10-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-11-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-12-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2026-02-01", "observed": 4, "expectedLow": null, "expectedHigh": null, "isSufficient": false } ], "sufficientMonths": 0, "method": null }, "signal": { "summary": "JIX (Calibrator, Multi-Analyte Mixture) has one finding. 1 recall opened in the last 12 months and not yet terminated (Z-2895-2026).", "severity": 70, "factors": [ { "kind": "recall", "detail": "1 recall opened in the last 12 months and not yet terminated", "recordIds": [ "Z-2895-2026" ], "severity": 70 } ], "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%3AJIX" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJIX" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJIX" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3AJIX" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AJIX" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AJIX" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AJIX" } ], "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": "2026-08-11T13:51:45.719Z" }