Siemens Dimension Vista Enzymatic Creatinine Reagent Recalled for Interference
Siemens Healthcare Diagnostics is recalling Dimension Vista Enzymatic Creatinine reagent because it may produce falsely depressed results for patients taking phenindione.
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 3/5 (High).
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 11,725 units of Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444. The recall covers all lots and is 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 text 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. Patients on phenindione therapy should consult their healthcare provider regarding the accuracy of recent creatinine test results.
The recalled product
- Product
- Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 11,725
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: 00842768036262 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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