Recall Z-2735-2014— Nanosphere, Inc.

Name: FDA recall Z-2735-2014
Creator: U.S. Food and Drug Administration
Published: 2013-06-17

Class II · Terminated

Class II FDA medical device recall by Nanosphere, Inc., initiated 2013-06-17, terminated 2016-03-14. It names one FDA 510(k) clearance: K122514. Product: Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers.. Reason: There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process SP Processing Error when used due to the Processor SP experiencing difficulty releasing the Tip to the final location in the Tip Assembly. The difficult releasing the Tip can result in a Processing Error and occasionally the Tip to be dropped into the Processor SP..

Recalling firm: Nanosphere, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-06-17
Terminated: 2016-03-14
Firm location: Northbrook, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K122514 — VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TESTNanosphere, Inc.·cleared 2012-09-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers.

Reason for recall

There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process SP Processing Error when used due to the Processor SP experiencing difficulty releasing the Tip to the final location in the Tip Assembly. The difficult releasing the Tip can result in a Processing Error and occasionally the Tip to be dropped into the Processor SP.

Data sourced from openFDA. This site is unofficial and independent of the FDA.