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Single (Specified) Analyte Controls (Assayed And Unassayed)

FDA product code JJX · Class 1 · Clinical Chemistry

1,660
Registered devices
693
Adverse events
42
Recalls
493
510(k) clearances

Devices with this code

Atellica IM TnI-Ultra MCM — Siemens Healthcare Diagnostics Inc.PreciControl Vitamin D total II — Roche Diagnostics GmbHOptilite® Freelite® Lambda Free Control Pack — THE BINDING SITE GROUP LIMITEDPreciControl HbA1c path — Roche Diagnostics GmbHPregnancy-Skreen — BIOCHEMICAL DIAGNOSTICS INCUrine Control — Chromsystems Instruments + Chemicals GmbHsLDL CONTROL - LEVEL 3 (sLDL CONTROL 3) — RANDOX LABORATORIES LIMITEDElecsys AntiTSHR Immunoassay — Roche Diagnostics GmbHCYSTATIN C CONTROL - LEVEL 2 (CYSC CONTROL 2) — RANDOX LABORATORIES LIMITEDIMMULITE® Systems fPS Calibration Verification Material Free PSA — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDAcrometrix EBV High Plasma Control — Microgenics CorporationOptilite® IgG3 Control Pack — THE BINDING SITE GROUP LIMITEDAtellica IM CA 19-9 MCM — Siemens Healthcare Diagnostics Inc.IMMULITE® Systems INS Calibration Verification Material Insulin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDADVIA Centaur® DHEA-S MCM — Siemens Healthcare Diagnostics Inc.Elecsys T3 CalCheck 5 — Roche Diagnostics GmbHARCHITECT — ABBOTT IRELANDFRUCTOSAMINE (FRUC) — RANDOX LABORATORIES LIMITEDARCHITECT — ABBOTT LABORATORIESIMMULITE® Systems T4 Calibration Verification Material Total T4 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCRP Quality Control Kit Level 3 — MEDICA CORPORATIONUASure uric acid control solution — APEX BIOTECHNOLOGY CORP.GLUCOCARD® Shine Level 2 Control Solution — ARKRAY USA, INC.ARCHITECT — Abbott GmbH

Recent recalls

DateFirmReason
2025-04-24Mckesson Medical-Surgical Inc. Corporate Officetransit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage con
2025-04-24Mckesson Medical-Surgical Inc. Corporate Officetransit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage con
2024-05-08Ortho-Clinical Diagnostics, Inc.The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 may cause range verification failure. The issue is
2024-01-09Mckesson Medical-Surgical Inc. Corporate OfficeFacility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated ran
2023-05-18Ortho-Clinical Diagnostics, Inc.May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
2023-01-09Siemens Healthcare Diagnostics, Inc.Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
2023-01-09Siemens Healthcare Diagnostics, Inc.Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
2023-01-09Siemens Healthcare Diagnostics, Inc.Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
2021-10-15Ortho-Clinical Diagnostics, Inc.Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained inf
2021-04-30Sentinel CH SpAClaim for stability after reconstitution from lyophilized to liquid form does not meet the requirements. New IFU instructions for handling the product provided

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.