Z-2236-2014Class II

Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test...

Name: Z-2236-2014 Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test...
Creator: Nanosphere, Inc.
Published: 2014-07-09
License: https://open.fda.gov/license/

Luminex Corporation / initiated 2014-07-09 / Terminated

FDA source

Nanosphere, Inc. began a recall of Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required... on 2014-07-09. FDA classified it as Class II and gives the reason as "Nanosphere Inc. has recently determined through four customer complaints that a small number of Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) Extraction Trays in Lot 042914021B have low levels or are...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2236-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-09
Posted: 2014-08-14
Terminated: 2015-09-01
Recalling firm: Luminex Corporation
Product: Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions, including wash solutions, oligonucleotide probe solution and signal amplification solutions required to generate a test result. BC-GN is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, is not used to monitor these infections.
Product code: PEN Gram-Negative Bacteria And Associated Resistance Markers
Reason for recall: Nanosphere Inc. has recently determined through four customer complaints that a small number of Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) Extraction Trays in Lot 042914021B have low levels or are missing Magnetic Microparticles (MMPs) required for DNA Extraction.
FDA root cause: Under Investigation by firm
Action: Nanosphere sent an Urgent Product Recall letter dated July 9, 2014 to all affected customers. All customers were initially notified of the recall by telephone on July 9, 2014. The customers were instructed to quarantine and return all affected product to Nanosphere. The letter included instructions: 1) on how to return the recalled products, and 2) to review any test results that were generated while using the recalled products to ensure that there has been no negative impact on patient care. Customers with questions were instructed to contact Nanosphere at 888-837-4436, option 2 or via e-mail at [email protected].
Quantity in commerce: 1045 extraction trays (840 affected by recall)
Distribution: Nationwide Distribution including CA, CO, IA, MT, OH, OK, OR, TX, and UT
Product codes and lots: VERIGENE BC-GN TEST KIT (Catalog Number: 20-005-021). TEST CARTRIDGES: Part Number: 20-006-021, Lot Number: 042914021B, Expiration Date: 10/26/14

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2236-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2236-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-14

Product code PEN

K132843Class IIVerigene Gram Negative Blood Culture Nucleic Acid Test (Bc-Gn)Nanosphere, Inc. / cleared 2014-01-08

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)