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Z-1956-2018 Class II Terminated

Recalled by Roche Molecular Systems, Inc. — Branchburg, NJ

FDA device recall Z-1956-2018 was initiated by Roche Molecular Systems, Inc. on May 2, 2018 and is designated Class II. Reason for recall: Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run. The recall status is terminated (terminated April 30, 2019). Affected quantity: 163 units.

Recall Details

Product Type
Devices
Report Date
June 6, 2018
Initiation Date
May 2, 2018
Termination Date
April 30, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
163 units

Product Description

MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucleic acids from various sample types, sample tubes, and volume inputs for multiple downstream applications. The main features of the system are : Scalable purification of 1 to 24 samples Primary/secondary tube handling Inventory and sample management via barcodes Efficient order management via host The MagNA Pure 24 System offers 4 run types: Purification (rack) run Purification (cartridge) run Post Elution run Sample transfer run

Reason for Recall

Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run.

Distribution Pattern

Worldwide Distribution - US Nationwide in the states of: CA, GA, HI, IN, MD, ME, MI, MN, NC, NY, PA, VI, and WI. The products were distributed to the following foreign countries: Austria, Belgium, Brazil, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, France, Germany, Guatemala, Hong Kong, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Singapore, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, UAE, United Kingdom, Vietnam.

Code Information

Device Identifier: 07613336106174

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FDA data resources