Siemens ADVIA Chemistry Enzymatic Creatinine Reagent Recalled for Interference
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Enzymatic Creatinine reagent because phenindione therapy can cause falsely depressed results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a potential for inaccurate results (falsely depressed creatinine) due to drug interference rather than a direct physical hazard or reported injury, fitting the criteria for moderate severity.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,015 units of ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869. The recall covers all lots and was distributed nationwide in the United States.
The recall was initiated because there is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. The source notes that this interference has not been observed with the creatinine Jaffe methodology.
Healthcare facilities and laboratories should stop using the affected reagent and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 1,015
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI Number: 00630414526690 Lots: All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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