Siemens Recalls ADVIA Centaur Cyclosporine Due to Labeling Error
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Cyclosporine because the instructions for use incorrectly state the biotin non-interference level.
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 incorrect labeling of a non-interfering substance level for a diagnostic test, which poses a risk of harm if results are misinterpreted, but no illnesses or injuries have been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur Cyclosporine (Lot codes: 38182025, 64432025, 98554025, 58299030, 25547030, 30153031, 77934031, 97170031). The recall affects units distributed nationwide and in Canada, Mexico, and Thailand.
The company is issuing this voluntary Class II recall because the concentrations for biotin listed in the non-interfering substances section of the instructions for use are incorrect. This error means the document does not accurately state the level at which biotin does not interfere with test results.
No information regarding reported illnesses, injuries, or specific consumer actions is provided in the source text.
The recalled product
- Product
- ADVIA Centaur¿ Cyclosporine
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
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)
- ADVIA Centaur¿ Cyclosporine
- Cyclosporine
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 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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