BioMerieux Recalls NucliSENS easyMAG Magnetic Silica Reagents
BioMerieux is recalling NucliSENS easyMAG Magnetic Silica reagents due to customer complaints about amplification performance issues.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Several customer complaints about amplification performance issues when using different batches of MagSil with the NucliSENS easyMAG extraction platform."
Plain-English summary
BioMerieux SA is recalling 7,845 units of NucliSENS easyMAG Magnetic Silica reagents. These products are used for the automated extraction of total nucleic acids from biological samples for in vitro diagnostic use by healthcare professionals.
The recall was initiated due to several customer complaints regarding amplification performance issues when using different batches of the MagSil product with the NucliSENS easyMAG extraction platform. The affected lots were distributed worldwide, including nationwide in the United States and in numerous international countries.
Healthcare professionals and laboratories should stop using the affected lots immediately and contact BioMerieux for further instructions or a return. The specific lot numbers affected are listed in the recall documentation.
The recalled product
- Product
- NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents and disposable to be used with the bioMerieux extraction systems which mention these products in their User Manuals. They enable the automated extraction (purification and concentration)…
- Manufacturer
- BioMerieux SA
- Hazard
- Affected units
- 7,845
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 (20)
- Lots - Z017BB1MS
- Z017BF1MS
- Z017CA1MS
- Z017BE1MS
- Z017CC1MS
- Z017CD1MS
- Z017CH1MS
- Z017BD1MS
- Z017DB1MS
- Z017BA1MS
- Z017CF1MS
- Z017CE1MS
- Z017CG1MS
- Z017DA1MS
- Z017DC1MS
- Z017DD1MS
- Z017EA1MS
- Z017EB1MS
- Z017FB1MS
- Z017KF1MS
Distribution
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