CLASS II Device recall · Reported 1 Oct 2014 · FDA Enforcement Report

The Verigene Gram-Positive Blood Culture Nucleic Acid Test recalled

Nanosphere is recalling The Verigene Gram-Positive Blood Culture Nucleic Acid Test (Bc-up) performed using the, distributed in 25 states. The recall was initiated on 10 Oct 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Number: 20-009-018; Lot Numbers and Expiration Dates: 1) Lot: 090613018B, Expiration Date: 03/05/14; 2) Lot: 091413018B, Expiration Date: 03/13/14; 3) Lot: 091713018C, Expiration Date: 03/16/14; 4) Lot: 091813018B, Expiration Date: 03/17/14; 5) Lot: 092113018C, Expiration Date: 03/20/14; 6) Lot: 100213018B, Expiration Date: 03/31/14

Quantity recalled4,440 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2683-2014
FDA event ID: 69034
Recalling firm: Nanosphere, Northbrook, IL
Classification: Class II
Status: Terminated
Recall initiated: 10 Oct 2013
FDA classified: 23 Sep 2014
Reported: 1 Oct 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Listeria
Device type: Patient Monitors

Timeline

10 Oct 2013	Recall initiated by company
23 Sep 2014	Classified by FDA	+348 days
1 Oct 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Listeria monocytogenes can grow at refrigerator temperatures. Infection is most dangerous for pregnant women, newborns, older adults and people with weakened immune systems. Symptoms can appear up to 70 days after eating contaminated food.

Product as listed by the FDA

The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). BC-UP is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria. BC-UP detects and identifies the following bacterial genera and species: Staphylococcus spp., Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Enterococcus faecalis, Enterococcus faecium, Streptococcus spp., Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus, group and Listeria spp. In addition, BC-UP detects the mnecA resistance marker, inferring mecA-mediated, methicillin resistance, and the vanA and vanB resistance markers, inferring vanA/vanB-mediated vancomycin resistance. In mixed growth, BC-UP does not specifically attribute van-mediated vancomycin resistance to either E. faecalis or E. faecium, or mecA-mediated methicillin resistance to either S. aureus or S. epidermidis. BC-UP is indicated for use in conjunction with other clinical and laboratory findings to, aid in the diagnosis of bacterial bloodstream infections; however, is not to be used to, monitor these infections. Sub-culturing of positive blood cultures is necessary to recover, organisms for susceptibility testing, identification of organisms not detected by BC-UP, differentiation of mixed growth, association of antimicrobial resistance marker genes to a specific organism, or for epidemiological typing.

Where it was distributed

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, South Korea, and Spain.

Arizona California Florida Georgia Iowa Illinois Indiana Kentucky Massachusetts Maryland Minnesota Missouri Montana North Carolina Nebraska New Jersey New York Ohio Oregon Pennsylvania

Questions about this recall

Why was it recalled?

Which lots are affected?

Product Number: 20-009-018; Lot Numbers and Expiration Dates: 1) Lot: 090613018B, Expiration Date: 03/05/14; 2) Lot: 091413018B, Expiration Date: 03/13/14; 3) Lot: 091713018C, Expiration Date: 03/16/14; 4) Lot: 091813018B, Expiration Date: 03/17/14; 5) Lot: 092113018C, Expiration Date: 03/20/14; 6) Lot: 100213018B, Expiration Date: 03/31/14

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 69034

This product is part of a recall event; the main page for the event is The Verigene Enteric Pathogens Nucleic Acid Test recalled by Nanosphere.

Reported	Class	Recall	Company	Reason	Where
1 Oct 2014	CLASS II	The Verigene Enteric Pathogens Nucleic Acid Test recalled by Nanosphere	Nanosphere	Salmonella	25 states
1 Oct 2014	CLASS II	The Verigene Respiratory Virus Plus Nucleic Acid Test recalled	Nanosphere	Device Malfunction	25 states
1 Oct 2014	CLASS II	The Verigene Clostridium difficile Nucleic Acid Test recalled	Nanosphere	Other Bacterial Contamination	25 states
1 Oct 2014	CLASS II	The Verigene Gram Negative Blood Culture Nucleic Acid Test recalled	Nanosphere	Other	25 states

More recalls from Nanosphere

All 11

Reported	Class	Recall	Company	Reason	Where
8 Oct 2014Device	CLASS II	Verigene Bc-gp Kit recalled by Nanosphere	Nanosphere	Other	Nationwide
8 Oct 2014Device	CLASS II	Verigene Bc-gn Kit recalled by Nanosphere	Nanosphere	Other	Nationwide
1 Oct 2014Device	CLASS II	The Verigene Gram Negative Blood Culture Nucleic Acid Test recalled	Nanosphere	Other	25 states
1 Oct 2014Device	CLASS II	The Verigene Clostridium difficile Nucleic Acid Test recalled	Nanosphere	Other Bacterial Contamination	25 states
1 Oct 2014Device	CLASS II	The Verigene Respiratory Virus Plus Nucleic Acid Test recalled	Nanosphere	Device Malfunction	25 states

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