Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
FDA adverse event reports and recall history for nad reduction/nadh oxidation, cpk or isoenzymes (product code CGS), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,513
- Deaths
- 0
- Injuries
- 2
- Malfunctions
- 1,510
Reports per year
Source: FDA adverse event reports by year received, 2007–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-12-01Open, ClassifiedNo Marketing Application
NAD Profile Test
Distribution without premarket approval/clearance.
- 2017-06-29TerminatedLabeling Change Control
Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.
Linear performance information in product insert does not match that listed in the approved premarket notification
- 2008-03-19TerminatedNonconforming Material/Component
Abbott Clinical Chemistry Creatine Kinase, Model LN 7D63-30, Lot Number: 52044HW00; Expires October 19, 2007, RCR#2018433-10/25/07-006R Abbott Laboratories, Inc., South Pasadena CA 91030
Three potential issues with Creatine Kinase Lot Number: 52044HW00: (1) Decrease in quality control and/or patient results (2) An iIncreased imprecision, or (3) Error Code 1054 (Unable to calculate results, Reaction Failure) on Architect cSystems.
- TerminatedMaterial/Component Contamination
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.
The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.
- TerminatedMaterial/Component Contamination
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.
The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.
- TerminatedUnder Investigation by firm
CK MB Calibrator, Catalogue Number CK2393
Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value will cause a positive shift of approximately 6% with both Quality Controls and Patient Samples.
- TerminatedDevice Design
Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.
- TerminatedDevice Design
Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/10464339) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.
- TerminatedNonconforming Material/Component
ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry XPT systems. The assay can be used to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as Duchenne progressive muscular dystrophy.
A steady upward trend in blank (u) absorbance was observed
- TerminatedNonconforming Material/Component
Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 - Product Usage: The ADVIA Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry XPT systems. The assay can be used to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as Duchenne progressive muscular dystrophy.
A steady upward trend in blank (u) absorbance was observed
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