Siemens Recalls Advia Chemistry Assay: Lactate Due to Interference
Siemens Healthcare Diagnostics is recalling Advia Chemistry Assay: Lactate units 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 is classified as FDA Class II. The hazard involves a risk of harm (falsely depressed diagnostic results) for a medical device, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 137,422 units of the Advia Chemistry Assay: Lactate (Catalog # 74051, Code E103611). The recall is due to confirmed interference from N-Acetylcysteine (NAC) and Metamizole (Dipyrone) in Trinder and Trinder-like reaction assays.
The company 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. The affected units were distributed nationwide across all 50 states, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, Guam, and the Pacific Mariana Islands.
Healthcare facilities and laboratories should stop using the affected assay kits and contact Siemens Healthcare Diagnostics for instructions on returning the product or obtaining replacements.
The recalled product
- Product
- Advia Chemistry Assay: Lactate
- 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)
- Lactate: E103611
- Catalog # (LAC) 74051
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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