Siemens ADVIA Chemistry Glucose Oxidase Assay Recalled for Interference
Siemens is recalling ADVIA Chemistry Glucose Oxidase 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 risk-of-harm product where injury has not yet been reported, as the hazard is potential diagnostic error due to chemical interference.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY, ADVIA Chemistry Glucose & Concentrated Glucose Oxidase Assay, and ADVIA Chemistry Glucose products. The recall involves 137,422 units distributed nationwide across all 50 states, DC, Puerto Rico, and U.S. territories.
The recall was initiated because Siemens became aware of interference from N-Acetylcysteine (NAC) and Metamizole (Dipyrone) with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving NAC or Metamizole. NAC is the accepted antidote for acetaminophen toxicity.
Healthcare facilities and laboratories should stop using the affected products and contact Siemens for instructions on how to return or replace the units. Patients who have had glucose tests performed using these assays should consult their healthcare provider if they are currently receiving NAC or Metamizole.
The recalled product
- Product
- ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose Oxidase Assay and ADVIA Chemistry Glucose.
- 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 (3)
- Device Listing: Glucose Oxidase (GLUO) D11793
- Catalog # 74020 & Concentrated Glucose Oxidase (GLUO_c) D117943
- Catalog # 74721
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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