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.
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, 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
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