The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and

FDA device recall Z-2685-2014 · posted 2014-09-23 · Terminated

Recall details

Recalling firm

Nanosphere, Inc.

Reason for recall

Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays.

Action taken

Nanosphere sent a Field Notification Letter dated October 10, 2013, to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. Instructions were included in the letter for customers to determine whether or not the extraction tray lots should be returned. If the extraction tray lots are to be returned, customers were to complete and return the attached form and replacement tip holder assemblies will be supplied at no cost. Customers could then dispose of the recalled unused tip holder assemblies. Customers with questions were instructed to contact their Nanosphere technical support representative. For questions regarding this recall call 1-888-837-4436, ext 3.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

PCH

Quantity affected

220 units

Distribution

Worldwide Distribution - USA including AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MN, MO, MT, NC, NE, NJ, NY, OH, OR, PA, TX, UT, VA, WA, WI, OH and Internationally to Bulgaria, Germany, Italy, Japan, So

Date initiated

2013-10-10

Date posted

2014-09-23

Date terminated

2015-06-16

Location

Northbrook, IL

Related 510(k) clearances