Home / Recalls / Nanosphere, Inc. / Z-2735-2014

Z-2735-2014 Class II Terminated

Recalled by Nanosphere, Inc. — Northbrook, IL

Recall Details

Product Type
Devices
Report Date
October 8, 2014
Initiation Date
June 17, 2013
Termination Date
March 14, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,660 extraction trays

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.

Distribution Pattern

Worldwide Distribution:US (Nationwide) including states of: AZ, CA, FL, IL, KY, MD, MN, MT, OH, PA, TN, TX, VA, WA, WI; and countries of: Belgium, China, and Saudi Arabia.

Code Information

Part Number: 20-009-018; Lot Numbers: 051713018B, 052413018C

Other recalls by Nanosphere, Inc.

  • Z-2236-2014 Class II — Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC- (July 9, 2014)
  • Z-2170-2014 Class II — Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using (April 17, 2014)
  • Z-2559-2014 Class III — Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of (March 18, 2014)
  • Z-2168-2014 Class III — Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Te (October 16, 2013)
  • Z-2683-2014 Class II — The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed usi (October 10, 2013)
  • Z-2682-2014 Class II — The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, mul (October 10, 2013)
  • Z-2684-2014 Class II — The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene Syst (October 10, 2013)
  • Z-2681-2014 Class II — The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed us (October 10, 2013)
  • Z-2685-2014 Class II — The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitat (October 10, 2013)
  • Z-2736-2014 Class II — Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartri (June 17, 2013)