CLASS II Device recall · Reported 1 Oct 2014 · FDA Enforcement Report
The Verigene Gram Negative Blood Culture Nucleic Acid Test recalled
Nanosphere is recalling The Verigene Gram Negative Blood Culture Nucleic Acid Test (Bc-gn), 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
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-2681-2014
- 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
- Other Reasons
- 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.
Product as listed by the FDA
The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. BC-GN is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram negative bacteria as determined by gram stain.
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.
ArizonaCaliforniaFloridaGeorgiaIowaIllinoisIndianaKentuckyMassachusettsMarylandMinnesotaMissouriMontanaNorth CarolinaNebraskaNew JerseyNew YorkOhioOregonPennsylvania
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Product Number: 20-009-021; Lot Number and Expiration Date: Lot: 100113021C, Expiration Date: 03/30/14
Where was it sold?
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.
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 69034This 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 |
|---|---|---|---|---|---|
| CLASS II | The Verigene Enteric Pathogens Nucleic Acid Test recalled by Nanosphere | Nanosphere | Salmonella | 25 states | |
| CLASS II | The Verigene Respiratory Virus Plus Nucleic Acid Test recalled | Nanosphere | Device Malfunction | 25 states | |
| CLASS II | The Verigene Clostridium difficile Nucleic Acid Test recalled | Nanosphere | Other Bacterial Contamination | 25 states | |
| CLASS II | The Verigene Gram-Positive Blood Culture Nucleic Acid Test recalled | Nanosphere | Listeria | 25 states |
More recalls from Nanosphere
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Verigene Bc-gp Kit recalled by Nanosphere | Nanosphere | Other | Nationwide |
| Device | CLASS II | Verigene Bc-gn Kit recalled by Nanosphere | Nanosphere | Other | Nationwide |
| Device | CLASS II | The Verigene Gram-Positive Blood Culture Nucleic Acid Test recalled | Nanosphere | Listeria | 25 states |
| Device | CLASS II | The Verigene Clostridium difficile Nucleic Acid Test recalled | Nanosphere | Other Bacterial Contamination | 25 states |
| Device | CLASS II | The Verigene Respiratory Virus Plus Nucleic Acid Test recalled | Nanosphere | Device Malfunction | 25 states |
Other Patient Monitors recalls
All 1,013| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |