Siemens Recalls ADVIA Centaur TnI-Ultra Assay Kits Due to Reagent Appearance
Siemens Healthcare Diagnostics is recalling ADVIA Centaur TnI-Ultra assay kits because a darker solid phase reagent in some lots may lead to incorrect test 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when there is a risk of adverse health consequences such as incorrect diagnostic results.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 34,283 kits of the ADVIA Centaur Systems TnI-Ultra assay. The recall affects specific catalog numbers and serial numbers, with kit lots ending in 078, 079, 082, 083, and 084. The products were distributed nationwide in the United States, including Puerto Rico, as well as in numerous countries worldwide.
The recall was initiated because the solid phase reagent in some of the ADVIA Centaur TnI-Ultra ReadyPacks, specifically lot 084, is darker in appearance. This visual difference creates a potential for incorrect control and patient results. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare facilities and laboratories that have received these kits should stop using the affected lots immediately. Users should contact Siemens Healthcare Diagnostics for instructions on how to return the products or obtain replacements. No specific instructions for individual consumers are provided as this is a professional medical device.
The recalled product
- Product
- ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 34,283
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 (5)
- Kit Lots Ending In: 078
- 079
- 082
- 083
- 084
Distribution
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