Siemens ADVIA Chemistry Enzymatic Creatinine 2 Recalled for Interference
Siemens is recalling ADVIA Chemistry Enzymatic Creatinine 2 reagents because N-Acetylcysteine and Metamizole can cause falsely depressed test 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 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 medical device that produces inaccurate diagnostic results, posing a risk of harm to patients through misdiagnosis or inappropriate treatment, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 13,742 units of ADVIA CHEMISTRY ENZYMATIC CREATININE_2 (Catalog # 74330). The recall is due to confirmed interference from N-Acetylcysteine (NAC) and Metamizole (Dipyrone) in Trinder and Trinder-like reaction assays.
The interference may result in falsely depressed creatinine test results for patients receiving NAC or Metamizole. NAC is the accepted antidote for acetaminophen toxicity. The affected units were distributed nationwide across all 50 states, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, Guam, and the Pacific Mariana Islands.
Healthcare facilities should contact Siemens Healthcare Diagnostics for instructions on how to return the affected product.
The recalled product
- Product
- ADVIA CHEMISTRY ENZYMATIC CREATININE_2
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 137,422
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 (2)
- Device Listing: Enzymatic Creatinine_2 D033075
- Catalog # 74330
Distribution
Part of a larger recall action
This product is one of 16 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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