FDA deems bioMérieux assay tech recall Class I

FDA sign

Molecular diagnostics player bioMérieux issued a recall for its NucliSENS easyMAG Magnetic Silica, which is used in several molecular assays to extract DNA and RNA from biological samples. The FDA has deemed the recall Class I.

The NucliSENS easyMag device is an automated system that uses magnetic silica to extract nucleic acids from biological samples--such as blood and tissue--for use in molecular infectious disease assays, molecular oncology assays and molecular genetics assays. The magnetic silica is being recalled because of its effects on nucleic acid extraction.

Kits with affected lots have shown a reduction in extraction performance with certain downstream applications, the FDA reported. This decline in performance could cause false negatives or invalid results for clinical lab tests and could ultimately result in serious adverse health consequences, including death.

The French diagnostics maker put out an Urgent Product Safety Correction Notice last week, instructing customers to, among other actions, review all results generated with the affected lots and to use internal and external extraction controls to screen for any problems with extraction performance. Biomérieux sent a prior safety correction notice in July.

The action follows another recall the FDA deemed Class I in January this year. In November, the company recalled 3,760 units of a test used to predict if a certain antibiotic will be useful in treating serious bacterial infections. The Etest PIP/TAZO/CON-4 PTC 256 might incorrectly show that the antibiotic PIP/TAXO slows or stops bacteria from growing, which could result in the wrong treatment for patients and lead to longer hospital stays, unnecessary procedures, sepsis and, in some cases, death.

- read more from the FDA

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FDA hits bioMérieux with Class I recall over antibiotic tests
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