Home › Device types › CJE
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
FDA product code CJE · Class 2 · Clinical Chemistry
85
Registered devices
73
Adverse events
22
Recalls
124
510(k) clearances
Devices with this code
Synermed® — INFRARED LABORATORY SYSTEMS LLCSynermed® — INFRARED LABORATORY SYSTEMS LLCGENCHEM™ Alkaline Phosphatase — GENCHEM INCAlkaline phosphatase acc. to IFCC Gen.2 — Roche Diagnostics GmbHSynchron — Beckman Coulter, Inc.Alkaline Phosphatase LiquiColor® — STANBIO LABORATORY, L.P.Alk Phos R1 (w/ssa#) — HORIBA INSTRUMENTS INCORPORATEDAlkaline Phosphatase (Kinetic Procedure) — TECO DIAGNOSTICSALP — RANDOX LABORATORIES LIMITEDCAROLINA LIQUID CHEMISTRIES CORP.® ALP RGT.KIT AU-206 — CAROLINA LIQUID CHEMISTRIES CORPORATIONAlkaline Phosphatase acc to IFCC Gen2 — Roche Diagnostics GmbHPointe Alkaline Phosphatase on the BS480 — HORIBA INSTRUMENTS INCORPORATEDSynermed® — INFRARED LABORATORY SYSTEMS LLCAU — Beckman Coulter, Inc.JAS Diagnostics — DREW SCIENTIFIC, INC.Thermo Scientific — Fisher DiagnosticsAlkaline Phosphatase (ALP) Kinetic Method TC Matrix-240/480 — TECO DIAGNOSTICSAlk Phos R1 (w/ssa#) — HORIBA INSTRUMENTS INCORPORATEDCAROLINA LIQUID CHEMISTRIES CORP.® CLC720 ALP RGT KIT Product No. ST206 — CAROLINA LIQUID CHEMISTRIES CORPORATIONARCHITECT — ABBOTT LABORATORIESAU — Beckman Coulter, Inc.Pointe Scientific Inc. — HORIBA INSTRUMENTS INCORPORATEDClearChem Diagnostics Inc. Alkaline Phosphatase (ALP) — CLEARCHEM DIAGNOSTICS INC.ALP — RANDOX LABORATORIES LIMITED
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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