The Recall Desk
HighFDA (Devices)·Z-1660-2016·Announced 2016-05-18

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.

What this means for you

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.
Category
Medical Device — In Vitro Diagnostics
Hazard
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

Distributed nationwide across the United States.

The notice also names 52 states specifically:

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.

See all 16 products in this recall →

Related recalls

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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Same hazard · interference

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