FDA MedWatch - NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents by bioMerieux: Recall - Potential Inaccurate Test Results

"FDA MedWatch" <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Fri, 27 Jan 2017 13:25:23 -0600

Title:     FDA MedWatch - NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents by bioMerieux: Recall - Potential Inaccurate Test Results

MedWatch - The FDA Safety Information and Adverse Event Reporting Program
  NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents by bioMerieux: Recall - Potential Inaccurate Test Results
AUDIENCE: Laboratory, Patient, Pathology
ISSUE: This is a continuation of bioMerieux's previous recall for NucliSENS easyMAG Magnetic Silica. The firm has identified additional affected product lots, and an additional product, the NucliSENS Magnetic Extraction Reagents, which have been determined to be in scope of the previous recall.
bioMerieux is recalling the NucliSENS reagents and accessory products due to a quality problem of the magnetic silica (MagSil) component. MagSil is used to extract and purify genetic material from patient samples.  Kits with the affected lots of the magnetic silica may not be able to fully extract nucleic acids from the sample and detect infection or provide proper diagnosis. The detection problem could lead to a risk of false negative results, invalid results, or under-quantification for clinical laboratory tests. This error may result in inappropriate treatment or delay in treatment. The use of the affected product may cause serious adverse health consequences, including death.
BACKGROUND: The NucliSENS easyMAG Magnetic Silica is used to extract nucleic acids (RNA or DNA) which contain genetic material from biological samples, such as blood, tissue, etc., which could then be used in various applications for molecular infectious disease assays, molecular oncology assays, and molecular genetics assays.
The NucliSENS Magnetic Extraction Reagents are accessory products that enable the automated extraction of RNA/DNA from biological samples. These products are intended for in vitro diagnostic use by health care professionals.
RECOMMENDATION: On November 23, 2016, bioMerieux sent Urgent Product Safety Correction Notices to affected customers. The notice asked customers to:

Distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred this product.
Use systematically an extraction internal control which mimics the extracted target (with same nature/structure), and/or external controls as recommended in the instructions for use and in good laboratory practices to detect any extraction performance issue.
In case of a detected issue, reduce the sample input volume to 200μl.
Discuss any concern regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action.
Contact your local customer service if you observe the issue.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the news release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm538682.htm

You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm 
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