BioMerieux 3D B.40 Software Update Recalled for Mislabeling Risk
BioMerieux is recalling 28 software updates for the 3D B.40 instrument due to a defect that may mislabel patient information on culture specimen bottles.
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 involves a software defect causing mislabeling of patient information, which is a significant data integrity issue but does not involve a direct physical hazard or reported injuries, fitting the criteria for a moderate severity labeling error.
Plain-English summary
BioMerieux Inc is recalling 28 kits of the 3D B.40 USB-ML04 clinical instrument software update, catalog number 412620. The software is used with a clinical instrument commonly employed to isolate and recover specimens from adult and older pediatric patients who are acutely ill with signs of bloodstream infection.
The recall was initiated because the product may mislabel patient information on culture specimen bottles due to a software miscommunication. This defect could lead to incorrect patient data being associated with clinical specimens.
The affected units were distributed worldwide, including in the United States and numerous international locations. The source text does not specify any reported illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412620 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older…
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 28
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)
- Identified by B.40 firmware
Distribution
Part of a larger recall action
This product is one of 31 recalled by Biomerieux 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.
See all 31 products in this recall →Related recalls
Same manufacturer · Biomerieux Inc
See all →- HighBiomerieux VITEK 2 AST-N461 Test Kit Recalled for Card Pouch Damage
FDA (Devices) · 2026-09-30
- HighVITEK 2 AST-N447 Test Kit Potentially Returns False Resistant Results
FDA (Devices) · 2026-07-15
- HighSusceptibility test cards recalled over false resistant antibiotic results
FDA (Devices) · 2026-02-11
- HighAntimicrobial susceptibility test cards recalled over false colistin resistance results
FDA (Devices) · 2025-10-08
- SevereVITEK 2 AST Test Kits: Ceftriaxone Concentration Error Risk
FDA (Devices) · 2024-05-01
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
- HighbioMerieux MYLA CLI Software Recalled for Patient Data Linking Errors
FDA (Devices) · 2015-12-23
- HighbioMerieux MYLA Software Recalled for Potential Patient Record Mismatch
FDA (Devices) · 2015-12-23
- HighbioMerieux MYLA Clinic Patch 3.3.0 Recalled for Patient Data Linking Error
FDA (Devices) · 2015-12-23
- HighbioMerieux MYLA Clinic Patch 3.2.0 CD Recall for Patient Data Linking Error
FDA (Devices) · 2015-12-23
- HighbioMerieux MYLA Software Recall for Potential Patient Record Mismatch
FDA (Devices) · 2015-12-23
- HighbioMerieux Recalls MYLA Software Due to Patient Data Linking Error
FDA (Devices) · 2015-12-23