Home › Device types › JJY
Multi-Analyte Controls, All Kinds (Assayed)
FDA product code JJY · Class 1 · Clinical Chemistry
1,543
Registered devices
121
Adverse events
92
Recalls
673
510(k) clearances
Devices with this code
Liquichek — BIO-RAD LABORATORIES, INC.PreciControl HIV Gen II — Roche Diagnostics GmbHMultichem S Plus — TECHNO-PATH MANUFACTURING LIMITEDValidate — Lgc Clinical Diagnostics, Inc.Liquichek — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.OPTI Check Plus — OPTI MEDICAL SYSTEMS, INC.Multichem IA Plus — TECHNO-PATH MANUFACTURING LIMITEDGEM System Evaluator 3 — INSTRUMENTATION LABORATORY COMPANYJAS Diagnostics — DREW SCIENTIFIC, INC.Mission Trinity R, Level 1,2,3 — Diamond Diagnostics Inc.LIQUID QC LIPID CONTROL LEVEL — CLINIQA CORPORATIONi-STAT — ABBOTT POINT OF CARE INC.Multichem S Plus — TECHNO-PATH MANUFACTURING LIMITEDABL80 SC80 — Radiometer Medical ApSContrIL 7 Multipak — INSTRUMENTATION LABORATORY COMPANYInteliQ — BIO-RAD LABORATORIES, INC.InteliQ — BIO-RAD LABORATORIES, INC.Validate — Lgc Clinical Diagnostics, Inc.ARCHITECT — ABBOTT LABORATORIESMultiqual — BIO-RAD LABORATORIES, INC.HQ-Chex — STRECK, INC.Multichem IA Plus — TECHNO-PATH MANUFACTURING LIMITEDLyphochek — BIO-RAD LABORATORIES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-17 | Microgenics Corporation | Vial-to-vial variability in MAS Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A results in low Parathyroid Hormone (PTH) |
| 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 |
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