FDA MedWatch - NucliSENS easyMAG Magnetic Silica for Nucleic Acid Extraction by BioMerieux: Recall - Potential Inaccurate Test Results

["FDA MedWatch" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA MedWatch - NucliSENS easyMAG Magnetic Silica for Nucleic Acid Extraction by BioMerieux: Recall - Potential Inaccurate Test Results

 

NucliSENS easyMAG Magnetic Silica for Nucleic Acid Extraction by BioMerieux: Recall - Potential Inaccurate Test Results

AUDIENCE: Laboratory, Patient, Pathology, Health Professional

ISSUE: BioMerieux is recalling the NucliSENS easyMAG Magnetic Silica (MagSil) because of effects on nucleic acids extraction performance. MagSil is used to extract and purify genetic material from patient samples. Kits with the affected lots of the Magnetic silica have exhibited a decrease of extraction performance with certain downstream applications. The detection problem could lead to a risk of false negative or invalid results for clinical laboratory tests. The use of the affected product may cause serious adverse health consequences, including death.

BACKGROUND: The NucliSENS easyMAG Magnetic Silica (MagSIL) is used to extract nucleic acids (RNA or DNA) 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. This may affect laboratories, health care providers and all patient groups receiving a diagnosis who utilize laboratories who use the NucliSENS easyMAG nucleic acid extraction system as part of diagnostic applications. Recall was initiated July 18, 2016; for a full list of distribution dates, see the Recall Notice.

RECOMMENDATION: On July 18, 2016 and on August 10, 2016, bioMerieux sent Urgent Product Safety Correction Notices to affected customers. Please follow the company’s second correction notice dated August 10, 2016 for detailed instructions. Please review all results that were generated with the affected lots of extraction reagent to determine the appropriate course of action. For additional instructions see the Recall Notice.
Healthcare professionals and consumers may report adverse reactions or quality problems they experienced using these devices to FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

• 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 Recall Notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm516545.htm

---

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

Follow MedWatch on Twitter

Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com.

This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).

---

This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 1-888-INFO-FDA (1-888-463-6332)