Home › Device types › CJE
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
FDA product code CJE · Class 2 · Clinical Chemistry
85
Registered devices
74
Adverse events
22
Recalls
124
510(k) clearances
Devices with this code
Synermed® — INFRARED LABORATORY SYSTEMS LLCACE — ALFA WASSERMANN, INC.Alkaline Phos/ BS480 — Medtest Dx, Inc.ACE — ALFA WASSERMANN, INC.CAROLINA LIQUID CHEMISTRIES CORP.® ALP ALKALINE PHOSPHATASE REAGENT CC206 — CAROLINA LIQUID CHEMISTRIES CORPORATIONSynchron — Beckman Coulter, Inc.Pointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDARCHITECT — Abbott GmbHALP — RANDOX LABORATORIES LIMITEDAlk Phos R1 (w/ssa#) — HORIBA INSTRUMENTS INCORPORATEDPointe Alkaline Phosphatase Reagent — HORIBA INSTRUMENTS INCORPORATEDIDG/Sanzay — IDG/SANZAY CorporationClearChem Diagnostics Inc. Alkaline Phosphatase (ALP) — CLEARCHEM DIAGNOSTICS INC.Alkaline Phosphatase LiquiColor® — STANBIO LABORATORY, L.P.JAS Diagnostics — DREW SCIENTIFIC, INC.Alkaline phosphatase liquid acc to IFCC — Roche Diagnostics GmbHAlkaline phosphatase acc to IFCC Gen2 — Roche Diagnostics GmbHALP — RANDOX LABORATORIES LIMITEDALP — RANDOX LABORATORIES LIMITEDAU — Beckman Coulter, Inc.Alkaline phosphatase liquid acc to IFCC — Roche Diagnostics GmbHPOINTE SCIENTIFIC Alkaline Phosphatase (Liquid) — HORIBA INSTRUMENTS INCORPORATEDSynermed® — INFRARED LABORATORY SYSTEMS LLCGENCHEM™ Alkaline Phosphatase — GENCHEM 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 |
| 2023-08-05 | Ortho-Clinical Diagnostics, INc. | Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not p |
| 2013-06-12 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
| 2011-08-26 | Abbott Laboratories, Inc | The reagent has the potential to be contaminated with mold, the Cladosporium fungal species. |
| 2008-02-07 | Pointe Scientific, Inc. | May be contaminated with microorganisms. |
| 2008-02-07 | Pointe Scientific, Inc. | May be contaminated with microorganisms. |
| 2008-02-07 | Pointe Scientific, Inc. | May be contaminated with microorganisms. |
| 2008-02-07 | Pointe Scientific, Inc. | May be contaminated with microorganisms. |
| 2008-02-07 | Pointe Scientific, Inc. | May be contaminated with microorganisms. |
| 2008-02-07 | Pointe Scientific, Inc. | May be contaminated with microorganisms. |
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