Siemens Recalls ADVIA Centaur BRAHMS PCT 100 Test Kits Due to Interference
Siemens Healthcare Diagnostics is recalling 16,302 ADVIA Centaur BRAHMS PCT 100 test kits because samples containing fluorescein may interfere with assay 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential for assay interference, which fits the criteria for a moderate severity score involving low-risk contamination or theoretical hazards without reported harm.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 16,302 kits of the ADVIA Centaur Systems BRAHMS PCT 100 test. The recall is due to the potential for samples containing fluorescein to show interference with the assay. The affected kits were sold only outside the United States (OUS) and are identified by catalog number 10378883.
The recall covers specific kit lots with expiration dates ranging from July 2014 to July 2015. The distribution pattern indicates worldwide distribution, including the United States (nationwide) and numerous international locations. The source text notes that this interference may also affect the ADVIA Centaur Systems TSH3 Ultra and Vitamin D assays.
Consumers and healthcare facilities should stop using the affected kits and contact Siemens Healthcare Diagnostics for instructions on how to return or dispose of the product.
The recalled product
- Product
- ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 10378883.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 16,302
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 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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