Siemens recalls Advia Chemistry Assays due to NAC and Metamizole interference
Siemens Healthcare Diagnostics is recalling Advia Chemistry 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 where a known interference can lead to inaccurate diagnostic results, posing a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Advia Chemistry Assays, specifically the Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol products. The recall involves 137,422 units distributed nationwide across all 50 states, Washington D.C., and U.S. territories.
The recall was initiated because Siemens confirmed that N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interfere with Trinder and Trinder-like reaction assays. This interference may result in falsely depressed test results for patients receiving these medications. NAC is the accepted antidote for acetaminophen toxicity.
Healthcare facilities and laboratories should stop using the affected products and contact Siemens Healthcare Diagnostics for instructions on how to return or dispose of the inventory.
The recalled product
- Product
- Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol
- 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)
- Cholesterol_2 (CHOL2): 74719 Cholesterol_concentrated (CHOL_c): 74718
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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