Home › Device types › CIT
Nadh Oxidation/Nad Reduction, Ast/Sgot
FDA product code CIT · Class 2 · Clinical Chemistry
140
Registered devices
89
Adverse events
13
Recalls
139
510(k) clearances
Devices with this code
JAS Diagnostics — DREW SCIENTIFIC, INC.AST — RANDOX LABORATORIES LIMITEDADVIA® Chemistry P5P Pyridoxal-5-Phosphate Reagents — Siemens Healthcare Diagnostics Inc.SGOT (AST) Reagent Kit — MEDICA CORPORATIONPiccolo General Chemistry 13 — ABAXIS, INC.Alinity — ABBOTT IRELANDAspartate aminotransferase acc to IFCC withwithout pyridoxal phosphate activat — Roche Diagnostics GmbHSirrus® AST/SGOT Liqui-UV® — STANBIO LABORATORY, L.P.Synchron — Beckman Coulter, Inc.Alinity — Abbott GmbHAST — RANDOX LABORATORIES LIMITEDAST — RANDOX LABORATORIES LIMITEDPointe AST on the BS480 Analyzer — HORIBA INSTRUMENTS INCORPORATEDPointe Scientific — HORIBA INSTRUMENTS INCORPORATEDJAS Diagnostics — DREW SCIENTIFIC, INC.AU — Beckman Coulter, Inc.AU — Beckman Coulter, Inc.Synermed® — INFRARED LABORATORY SYSTEMS LLCBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.ARCHITECT — ABBOTT IRELANDADVIA® Chemistry P5P Pyridoxal-5-Phosphate Reagents — Siemens Healthcare Diagnostics Inc.CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 AST RGT KIT Product No. ST241 — CAROLINA LIQUID CHEMISTRIES CORPORATIONBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.Synermed® — INFRARED LABORATORY SYSTEMS LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-09-06 | Randox Laboratories Ltd. | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below |
| 2017-06-29 | Siemens Healthcare Diagnostics, Inc. | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine |
| 2017-06-29 | Siemens Healthcare Diagnostics, Inc. | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine |
| 2014-08-11 | ELITech Clinical Systems SAS | Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing that Quality Control (QC) fails before the product expiry is reach |
| 2014-03-05 | Alfa Wassermann, Inc. | Extremely low absorbance readings. |
| 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. |
| 2012-10-10 | Horiba Instruments, Inc dba Horiba Medical | Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was |
| 2012-02-15 | Medtest Holdings, Inc. | A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations section indicates linearity is 500 U/L and the Performance section linearity is list |
| 2008-08-25 | Pointe Scientific, Inc. | The R1 component may be contaminated with Serratia liquefaciens, resulting decreased absorbances and failure of the reagent to produce test results. |
| 2008-08-25 | Pointe Scientific, Inc. | The R1 component may be contaminated with Serratia liquefaciens, resulting decreased absorbances and failure of the reagent to produce test results. |
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