Home › Device types › JJX
Single (Specified) Analyte Controls (Assayed And Unassayed)
FDA product code JJX · Class 1 · Clinical Chemistry
1,645
Registered devices
672
Adverse events
42
Recalls
493
510(k) clearances
Devices with this code
LEADER — Cardinal Health 110, Inc.Lipase NG OC CTRL 2 — SENTINEL CH. SPAisatuximab CONTROL — SEBIAEmbraceWAVE Glucose Control Solution High (L2) — OMNIS HEALTH, LLCVITROS — ORTHO CLINICAL DIAGNOSTICSAtellica IM T4 MCM — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott Ireland DiagnosticsPreciControl Rubella IgG — Roche Diagnostics GmbHInteliQ — BIO-RAD LABORATORIES, INC.Atellica IM LH MCM — Siemens Healthcare Diagnostics Inc.BD Veritor™ System Flu A+B Control Swab Set — BECTON, DICKINSON AND COMPANYCONTOUR® NEXT LINK — ASCENSIA DIABETES CARE US INC.CAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 2 CONTROL KIT PART# CC052 — CAROLINA LIQUID CHEMISTRIES CORPORATIONOptilite® Anti-streptolysin O Control Pack — THE BINDING SITE GROUP LIMITEDG-6-PDH DEFICIENT CONTROL (G-6-PDH CONTROL D) — RANDOX LABORATORIES LIMITEDAlinity — Abbott GmbHMAS Diabetes Liquid Assayed Diabetes Control — Microgenics CorporationBioPlex 2200 — BIO-RAD LABORATORIES, INC.VITROS — ORTHO CLINICAL DIAGNOSTICSPanther Fusion® — Hologic, Inc.IMMULITE® GROWTH HORMONE CVM — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDEurotrol GlucoTrol-NG — Eurotrol B.V.Freelite Kappa Free Panel Sample Set — THE BINDING SITE GROUP LIMITEDCURO L5 Total Cholesterol Strips — KPI HEALTHCARE, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage con |
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage con |
| 2024-05-08 | Ortho-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 |
| 2024-01-09 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated ran |
| 2023-05-18 | Ortho-Clinical Diagnostics, Inc. | May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU). |
| 2023-01-09 | Siemens Healthcare Diagnostics, Inc. | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. |
| 2023-01-09 | Siemens Healthcare Diagnostics, Inc. | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. |
| 2023-01-09 | Siemens Healthcare Diagnostics, Inc. | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. |
| 2021-10-15 | Ortho-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 |
| 2021-04-30 | Sentinel CH SpA | Claim 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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