Siemens Atellica CH Enzymatic Creatinine Reagent Recalled for Interference
Siemens Healthcare Diagnostics is recalling Atellica CH Enzymatic Creatinine reagent due to potential falsely depressed results for patients on phenindione therapy.
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 824 units of Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533. 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 when using the enzymatic methodology 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 or replacement.
The recalled product
- Product
- Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 824
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: 00630414595795 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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