Siemens ADVIA Salicylate Reagent Recalled for Potential Test Interference
Siemens Healthcare Diagnostics is recalling ADVIA Salicylate reagent chemistry assays because various blood, urine, or cerebrospinal fluid assays may interfere with sulfasalazine and sulfapyridine, causing falsely elevated or depressed salicylate 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 FDA Class II. The hazard involves potential for incorrect medical test results (falsely elevated or depressed salicylate levels) due to drug interference, which poses a risk of harm if misdiagnosis occurs, but no illnesses or injuries have been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA Salicylate (SAL) reagent chemistry assay, product number 10327382, manufactured by Sekisui Diagnostics. The recall affects a quantity of 1,667 units with all lots included.
The reason for the recall is that various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine. This interference can cause falsely elevated or falsely depressed results when using the recalled reagent for the quantitative determination of salicylate in human serum and plasma (lithium heparin).
The affected product was distributed in all 50 U.S. states, the District of Columbia, Guam, Puerto Rico, and 108 foreign countries.
No specific consumer actions are detailed in the provided source text beyond the identification of the recall.
The recalled product
- Product
- ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium heparin). Product Number: 10327382 (Mfr: Sekisui Diagnostics)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 1,667
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)
- All lots
Distribution
Part of a larger recall action
This product is one of 17 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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