BioMerieux NucliSENS Magnetic Extraction Reagents Recalled Due to Temperature Exposure
BioMerieux is recalling 42 units of NucliSENS Magnetic Extraction Reagents because data loggers indicated one shipment experienced low temperatures that may impact performance.
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, and the hazard is a potential performance impact due to temperature exposure without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
BioMerieux SA is recalling 42 units of NucliSENS Magnetic Extraction Reagents. The recall is being conducted because data loggers showed that one shipment to the United States experienced low temperatures that may impact the performance of the product.
The affected product is identified by Reference # 200293, Lot # 17121501, and has an expiration date of 11/28/2018. The products were distributed nationwide to Maryland, Texas, Massachusetts, Georgia, Ohio, Oregon, California, and Washington.
Consumers and healthcare facilities should stop using the affected product and contact BioMerieux SA for further instructions or a return.
The recalled product
- Product
- NucliSENS¿ Magnetic Extraction Reagents
- Manufacturer
- BioMerieux SA
- Hazard
- Affected units
- 42
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 (3)
- Reference # 200293
- Lot # 17121501
- Expiration date 11/28/2018
Distribution
Related recalls
Same manufacturer · BioMerieux SA
See all →- HighMYLA Diagnostic System Software Versions Recalled for Risk of False Negatives
FDA (Devices) · 2021-10-20
- HighMYLA Laboratory Software: Potential Test Result Alteration from Software Anomaly
FDA (Devices) · 2021-08-18
- ModerateBioMerieux Recalls VIDAS FSH Assay Kits Due to Calibration Issues
FDA (Devices) · 2018-07-04
- ModerateBioMérieux Recalls Color Gram 2 Stains Due to Temperature Excursion
FDA (Devices) · 2018-06-20
- ModerateBioMérieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Temperature Excursion
FDA (Devices) · 2018-06-20
Same hazard · performance impact
See all →- LowDiamedix Is-Mumps IgG Test Kit Recalled for Gel-Like Contaminant
FDA (Devices) · 2018-08-08
- ModerateSekisui Diagnostics Ammonia L3K Assay Recalled for Performance Issues
FDA (Devices) · 2017-02-01
- ModeratePhilips Ingenuity CT Software Recall for Performance Issues
FDA (Devices) · 2016-08-17