Z-2735-2014Class II

Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartridges; are qualitative...

Name: Z-2735-2014 Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartridges; are qualitative...
Creator: Nanosphere, Inc.
Published: 2013-06-17
License: https://open.fda.gov/license/

Luminex Corporation / initiated 2013-06-17 / Terminated / root cause: packaging

FDA source

Nanosphere, Inc. began a recall of 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... on 2013-06-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2735-2014
Classification: Class II
Status: Terminated
Initiated: 2013-06-17
Posted: 2014-09-30
Terminated: 2016-03-14
Recalling firm: Luminex Corporation
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.
Product code: PAM Gram-Positive Bacteria And Their 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.
Root cause tag: packaging
FDA root cause: Process change control
Action: Undated recall notification letters were sent to all direct accounts (customers) June 17 - 19, 2013. The letters included instructions for customers to: 1) check their inventory for the recalled products; 2) set any recalled products aside for return; and, 3) contact Nanosphere to obtain replacement tip holders. Customers with questions about this recall can contact Nanosphere via e-mail at [email protected] or by calling 888-837-4436.
Quantity in commerce: 1,660 extraction trays
Distribution: 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.
Product codes and lots: Part Number: 20-009-018; Lot Numbers: 051713018B, 052413018C

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2735-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2735-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-08	2014-09-30
Z-2736-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-08	2014-09-30

Product code PAM

K122514Class IIVerigene Gram-Positive Blood Culture (Gc-Gp) Nucleic Acid TestNanosphere, Inc. / cleared 2012-09-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)