Home › Device types › JJY
Multi-Analyte Controls, All Kinds (Assayed)
FDA product code JJY · Class 1 · Clinical Chemistry
1,514
Registered devices
121
Adverse events
91
Recalls
673
510(k) clearances
Devices with this code
Vigil — Beckman Coulter, Inc.DImension Vista® Protein 2 Control L — Siemens Healthcare Diagnostics Products GmbHABL80 SC80 — Radiometer Medical ApSElecsys Calcitonin CalCheck 5 — Roche Diagnostics GmbHPreciControl MultiMarker — Roche Diagnostics GmbHCARDIAC CONTROL - LEVEL 3 (CRD CONTROL 3) — RANDOX LABORATORIES LIMITEDMultichem S — TECHNO-PATH MANUFACTURING LIMITEDK-ASSAY® ASO/RF/CRP Control — KAMIYA BIOMEDICAL COMPANY, LLCLiquichek — BIO-RAD LABORATORIES, INC.Multichem S Plus — TECHNO-PATH MANUFACTURING LIMITEDValidate — Lgc Clinical Diagnostics, Inc.small dense LDL Control Set — DENKA COMPANY LIMITEDRAPIDQC® Complete Level 2 — Siemens Healthcare Diagnostics Inc.Serum Control — Chromsystems Instruments + Chemicals GmbHCOAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1) — RANDOX LABORATORIES LIMITEDGEM System Evaluator 3 — INSTRUMENTATION LABORATORY COMPANYABL80 SC80 — Radiometer Medical ApSSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONWhole Blood Matrix — MORE DIAGNOSTICS INCK-ASSAY® Liquid ITA Control — KAMIYA BIOMEDICAL COMPANY, LLCHQ-Chex — STRECK, INC.VALIDATE — Lgc Clinical Diagnostics, Inc.ARCHITECT — Abbott Ireland DiagnosticsLiquichek — BIO-RAD LABORATORIES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-06 | POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC | A labeling error was identified on the affected product. The expiration date on the kit box label and on the vial labels incorrectly stated the expiration date |
| 2025-10-01 | Microgenics Corporation | The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may l |
| 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 |
| 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 |
| 2024-02-27 | Ortho-Clinical Diagnostics | The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Qua |
| 2024-02-27 | Ortho-Clinical Diagnostics | The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Qua |
| 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 |
| 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 |
| 2023-08-25 | TECHNO-PATH MANUFACTURING LTD. | Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill the Multichem S Plus Level 1, Multichem S Plus Level 2, Multich |
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