bioMérieux NucliSENS easyMAG Lysis Buffer Recalled for Colored Eluates
bioMérieux is recalling NucliSENS easyMAG Lysis Buffer because some eluates become colored due to remaining hemoglobin.
What this means for you
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 describes a quality defect (colored eluates) without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
bioMérieux, Inc. is recalling 268 units of NucliSENS easyMAG Lysis Buffer (ref. 280134) under FDA recall number Z-0443-2019. The product is classified as an FDA Class II recall.
The recall was initiated because some eluates become colored due to remaining hemoglobin in the eluate. This issue affects Lot Z019EA1LB, which has an expiration date of 28-MAY-2019.
The affected units were distributed in the United States (CA, FL, GA, MD, MI, MN, NC, NJ, NM, NY, OH, OR, RI, SC, TN, TX, VA, WA, and WI) and internationally (Austria, Australia, Belgium, Switzerland, Colombia, Germany, Spain, France, UK, India, Italy, Japan, Netherlands, Portugal, Sweden, Singapore, South Africa, Israel, Dutch Antilles, Angola, Estonia, and Bangladesh). Users should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- Product
- bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134
- Manufacturer
- bioMerieux, Inc.
- Hazard
- Affected units
- 268
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)
- Lot Z019EA1LB Exp. 28-MAY-2019.
Distribution
Related recalls
Same manufacturer · bioMerieux, Inc.
See all →- 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
- HighMedical Device Middleware: MYLA Software Fails to Apply AST Filter Rules
FDA (Devices) · 2023-03-08
Same hazard · quality defect
See all →- ModerateDicyclomine Hydrochloride Capsules Recalled for Empty Capsules
FDA (Drugs) · 2026-08-12
- ModerateMethohexital Sodium for Injection Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-15
- ModerateMedline Lidocaine HCL Injection Ampules Recalled for Quality Issues
FDA (Devices) · 2026-07-08
- ModerateMedline Convenience Kits Block Tray recalled due to quality defects
FDA (Devices) · 2026-07-08
- ModerateMedline Ophthalmic Pack with Lidocaine Injection Kits Recalled
FDA (Devices) · 2026-07-08