bioMerieux Recalls NUCLISENS Lysis Buffer Due to pH Electrode Dysfunction
bioMerieux is recalling NUCLISENS Lysis Buffer, Lot 19040201, because pH electrode dysfunction caused colored eluates and invalid test results.
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. The hazard involves invalid test results due to a manufacturing defect (pH electrode dysfunction) rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity recall.
Plain-English summary
bioMerieux is recalling NUCLISENS Lysis Buffer, Reference 200292, Lot 19040201. The product is an in vitro diagnostic (IVD) reagent used to release total nucleic acid from biological specimens.
The recall was initiated following a customer complaint regarding colored eluates, which led to invalid test results. bioMerieux confirmed that the issue is linked to pH electrode dysfunction during the manufacturing process.
The affected lot has an expiry date of February 28, 2021. The source text indicates that there was no US distribution and no Mexican consignees for this lot. The product was distributed internationally to South Africa, Uruguay, Tanzania, Romania, Netherlands, Macao, Italy, India, Hong Kong, United Kingdom, France, Spain, Germany, China, Chile, Canada, Belgium, Australia, Argentina, and Curacao. Users should stop using the affected lot and contact the manufacturer for further instructions.
The recalled product
- Product
- NUCLISENS¿ Lysis Buffer, IVD, REF 200292, 48X2 ML LYS Manufacturer bioMerieux SA 376, Chemin de l'Orme 69280 Marcy-l'Etoile - France - Product Usage: to be used for the release of total nucleic acid from biological specimens.
- Manufacturer
- BIOMERIEUX - Grenoble
- Affected units
- 1,024
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 19040201
- Expiry 28-Feb-2021
Distribution
Distribution scope not specified by the agency.
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