Siemens Dimension Enzymatic Creatinine Assay Recalled for Interference
Siemens Healthcare Diagnostics is recalling Dimension Enzymatic Creatinine 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 can produce falsely depressed results, posing a risk of harm through misdiagnosis or treatment errors, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 137,422 units of Dimension Assays: ENZYMATIC CREATININE. The recall is due to interference from N-Acetylcysteine (NAC) and Metamizole (Dipyrone) in Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving these medications.
The affected products were distributed nationwide across all 50 states, the District of Columbia, Puerto Rico, St. Thomas, the Virgin Islands, Guam, and the Pacific Mariana Islands. The specific device listing is D089144 (Enzymatic Creatine (ECRE) Catalog # DF270B).
Healthcare facilities and laboratories should stop using the affected assays and contact Siemens Healthcare Diagnostics for further instructions. Patients who have had creatinine tests performed using these assays while receiving NAC or Metamizole should consult their healthcare provider to discuss the potential for inaccurate results.
The recalled product
- Product
- Dimension Assays: ENZYMATIC CREATININE
- 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 (1)
- Device Listing: D089144(Enzymatic Creatine (ECRE) Catalog # DF270B
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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