Home › Device types › CKA
Nadh Oxidation/Nad Reduction, Alt/Sgpt
FDA product code CKA · Class 1 · Clinical Chemistry
137
Registered devices
92
Adverse events
18
Recalls
127
510(k) clearances
Devices with this code
Synchron — Beckman Coulter, Inc.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.AU — Beckman Coulter, Inc.Piccolo General Chemistry 13 — ABAXIS, INC.Teco Diagnostics TC Matrix Clinical Chemistry Analyzer — TECO DIAGNOSTICSALT / BS200 — Medtest Dx, Inc.ARCHITECT — ABBOTT IRELANDALANINE AMINOTRANSFERASE (ALT) — RANDOX LABORATORIES LIMITEDALANINE AMINOTRANSFERASE (ALT) — RANDOX LABORATORIES LIMITEDALT (SGPT) REAGENT SET (UV-KINETIC METHOD) — TECO DIAGNOSTICSBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.ARCHITECT — Abbott GmbHALANINE AMINOTRANSFERASE (ALT) — RANDOX LABORATORIES LIMITEDALT / BS480 — Medtest Dx, Inc.Synermed® — INFRARED LABORATORY SYSTEMS LLCARCHITECT — ABBOTT LABORATORIESAlinity — Abbott GmbHJAS Diagnostics — DREW SCIENTIFIC, INC.AU — Beckman Coulter, Inc.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.Synermed® — INFRARED LABORATORY SYSTEMS LLCJAS Diagnostics — DREW SCIENTIFIC, INC.ALANINE AMINOTRANSFERASE (ALT) — RANDOX LABORATORIES LIMITED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-06-10 | Abbott Laboratories | There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for |
| 2021-06-10 | Abbott Laboratories | There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for |
| 2021-06-10 | Abbott Laboratories | There is a potential for 15% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a |
| 2021-06-10 | Abbott Laboratories | There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for |
| 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 |
| 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 |
| 2016-07-20 | Sterling Diagnostics, Inc. | Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the k |
| 2014-03-05 | Alfa Wassermann, Inc. | Extremely low absorbance readings. |
| 2010-11-19 | Abaxis, Incorporated | Abaxis has determined that during the manufacture of product lot 0396BC5 may report inaccurate values of Alanine Aminotransferase (ALT) when used in the Piccolo |
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