Siemens Dimension Enzymatic Creatinine Reagent Recalled for Interference
Siemens Healthcare Diagnostics is recalling Dimension Enzymatic Creatinine reagent because it may produce falsely low results for patients taking phenindione.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device reagent) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 2,198 units of Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520. The recall covers all lots and was distributed nationwide in the United States.
The recall is due to a potential for falsely depressed creatinine results when the enzymatic methodology is used for patients on phenindione therapy. The source notes that this interference has not been observed with the creatinine Jaffe methodology.
Healthcare facilities should stop using the affected reagent for patients on phenindione therapy. Consumers should contact their healthcare provider if they have had recent creatinine tests using this specific reagent while taking phenindione.
The recalled product
- Product
- Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 2,198
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: 00842768030512 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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