Siemens Recalls ADVIA Centaur BNP Assay Reagents Due to Labeling Error
Siemens Healthcare Diagnostics is recalling ADVIA Centaur BNP Assay reagents because approximately 2,000 ReadyPacks contain an incorrect human-readable side label.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition indicates a violation of labeling or FDA regulations that is not likely to cause adverse health consequences. The issue is a labeling error on the reagent packaging.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur BNP Assay reagents used for in vitro diagnostic testing of B-type Natriuretic Peptide (BNP) in human plasma. The recall involves approximately 2,000 ReadyPacks from the ADVIA Centaur Systems BNP reagent line.
The recall was initiated because the affected ReadyPacks contain an ADVIA Centaur Systems FT4 human-readable side label, which is incorrect for the BNP assay. The affected products include catalog numbers 02816138/SMN 10309044 (100 test) and 02816634/SMN 10309045 (500 test), specifically Lot 038174 with codes 43305174, 43278174, 43306174, and 43279174.
The affected products were distributed worldwide, including the United States (nationwide including Puerto Rico), Canada, and numerous countries in Europe, Asia, the Americas, and Africa. Healthcare facilities and laboratories should check their inventory for the specific lot and catalog numbers listed and stop using the affected reagents. Siemens Healthcare Diagnostics is the recalling firm.
The recalled product
- Product
- ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers: Cat No. 02816138/SMN 10309044 (100 test) 02816634/SMN 10309045…
- 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)
- Lot 038174: 100 Test - 43305174 and 43278174
- 500 Test - 43306174 and 43279174.
Distribution
Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc
See all →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateSiemens ADVIA Centaur CP BNP Kit Recalled for Failed Calibration
FDA (Devices) · 2014-08-13
- ModerateSiemens ADVIA Centaur BNP Assay Recalled for Potential Analyzer Malfunction
FDA (Devices) · 2018-06-13
- ModerateSiemens Healthcare BNP Test Kit Recalled for Temperature Sensitivity
FDA (Devices) · 2012-12-19
- ModerateSiemens Recalls ADVIA Centaur Insulin Assay Kits Due to Accuracy Issues
FDA (Devices) · 2017-05-24
- ModerateSiemens ADVIA Centaur Immunoassay Systems Recalled for Sample Rack Loading Issues
FDA (Devices) · 2014-09-24
- SevereSiemens Recalls ADVIA Centaur TnI-Ultra Assay Kits Due to Reagent Appearance
FDA (Devices) · 2014-07-09