FDAClass IAugust 17, 2016

NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG recall

NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents and disposable to be used with the bioMerieux extraction…

Why was NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG recalled?

Several customer complaints about amplification performance issues when using different batches of MagSil with the NucliSENS easyMAG extraction platform.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lots - Z017BB1MS, Z017BF1MS, Z017CA1MS, Z017BE1MS, Z017CC1MS, Z017CD1MS, Z017CH1MS, Z017BD1MS, Z017DB1MS, Z017BA1MS, Z017CF1MS, Z017CE1MS, Z017CG1MS, Z017DA1MS, Z017DC1MS, Z017DD1MS, Z017EA1MS, Z017EB1MS, Z017FB1MS, Z017KF1MS, Z017KG1MS, Z017KH1MS

Product
NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents and disposable to be used with the bioMerieux extraction…
Recalling firm
BioMerieux SA
Quantity
7,845 units
Distribution
Worldwide Distribution - US Nationwide in the states of: AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MO, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, and the countries of Angola, Argentina, Austria, Australia, Austria, Botswana, Brazil, Burkina Faso, Cambodia, China, Colombia, Djibouti Antilles, Estonia, Georgia, Germany, Greece, India, Israel, Italy, Kuwait, Latvia, Malaysia, Mexico, Netherlands, Poland, Qatar, Russia, Senegal, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Zambia, and Zimbabwe
Recall date
August 17, 2016
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls