Siemens Dimension Vista Enzymatic Creatine Assays Recalled for Interference
Siemens is recalling Dimension Vista Enzymatic Creatine assays because N-Acetylcysteine and Metamizole 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 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 (falsely depressed creatine levels) for patients on specific medications, posing a risk of harm through misdiagnosis or treatment errors, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Dimension Vista Assays: Enzymatic Creatine (ECRE) due to interference from N-Acetylcysteine (NAC) and Metamizole (Dipyrone). The recall affects 137,422 units of the assay, identified by Device Listing D089144 and Catalog # K1270A.
The recall was initiated because Siemens confirmed that falsely depressed results may occur on samples drawn from 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, St. Thomas, the Virgin Islands, Guam, and the Pacific Mariana Islands.
Healthcare facilities and laboratories should stop using the affected Dimension Vista Enzymatic Creatine assays and contact Siemens Healthcare Diagnostics for further instructions on the recall process.
The recalled product
- Product
- Dimension Vista Assays: Enzymatic Creatine (ECRE)
- 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: D089144 Enzymatic Creatinine (ECRE)
- Catalog # K1270A
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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