BioMerieux 3D IND ZIP-ML Software Update Recalled for Mislabeling
BioMerieux is recalling 288 units of the 3D IND ZIP-ML software update because a defect may cause patient information to be mislabeled 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 is classified as FDA Class II, and the hazard is a labeling error (mislabeling patient information) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
BioMerieux Inc is recalling 288 units of the 3D IND ZIP-ML software update, catalog number 412005. This software is used with instruments that 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. The affected units are identified by B.40 firmware.
The recall covers worldwide distribution, including the United States and numerous international locations. No specific instructions for consumers are provided in the source text.
The recalled product
- Product
- bioMerieux Kit, Instrument & Update, 3D IND ZIP-ML 01, Industry instrument software update, English, Spanish, Italian, catalog number 412005 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric…
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 288
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
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- HighbioMerieux MYLA CLI Software Recalled for Patient Data Linking Errors
FDA (Devices) · 2015-12-23
- ModerateBioMerieux Vitek 2 Software Recall for Antibiotic Code Errors
FDA (Devices) · 2013-08-14
- HighbioMerieux MYLA Software Recalled for Potential Patient Record Mismatch
FDA (Devices) · 2015-12-23
- ModerateBioMerieux Vitek 2 Software Version 6.01 Recalled for Interface Errors
FDA (Devices) · 2013-08-14
- ModerateBioMérieux Vitek 2 Software Version 6.01 Recalled for Interface Errors
FDA (Devices) · 2013-08-14
- ModerateBioMérieux Vitek 2 Software Version 6.01 Recalled for Interface Error
FDA (Devices) · 2013-08-14