Enzymatic Method, Creatinine
FDA adverse event reports and recall history for enzymatic method, creatinine (product code JFY), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 561
- Deaths
- 0
- Injuries
- 14
- Malfunctions
- 546
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2020-06-05TerminatedDevice Design
ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
- 2020-06-05TerminatedDevice Design
Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
- 2020-06-05TerminatedDevice Design
Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
- 2020-06-05TerminatedDevice Design
Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number 00842768036262 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
- 2020-01-24TerminatedUnder Investigation by firm
ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869
There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.
- 2020-01-24TerminatedUnder Investigation by firm
Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.
- 2020-01-24TerminatedUnder Investigation by firm
Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520
There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.
- 2020-01-24TerminatedUnder Investigation by firm
Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.
- 2017-06-27TerminatedNonconforming Material/Component
MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems The product is a medical device (chemistry reagent) and is intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems. The kit is provided as a ready to use liquid material consisting in two components: Reagent 1 and Reagent 2. According to the catalogue number, the kit is composed of three vials of 48 ml for Reagent 1 and three vials of 18 ml for Reagent 2 in the configuration 8L24-31. The configuration 8L24-41 consists in ten vials of 90 ml for Reagent 1 and ten vials of 34 ml for Reagent 2
Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration.
- 2015-09-05TerminatedDevice Design
Dimension CREA (Creatinine) and Dimension Vista CREA (Creatinine); The CREA method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of creatinine in human serum, plasma and urine.
Siemens has confirmed that the Dimension CREA and Dimension Vista CREA may produce falsely depressed results up to - 12.7% and -22% respectively, for a creatinine concentration of 1.5 mg/dL when hemolysis exceeds 200 mg/dL and 300 mg/dL respectively.
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