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

The Verigene Enteric Pathogens Nucleic Acid Test recalled by Nanosphere

Nanosphere is recalling The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test, distributed nationwide in the US. 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: (Not Applicable); Lot Numbers and Expiration Dates: 1) Lot: 091313023CIUO, Expiration Date: 03/12/14; 2) Lot 092713023CIUO, Expiration Date: 03/26/14

Quantity recalled220 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-2685-2014
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: Salmonella
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.

Salmonella causes fever, diarrhea and abdominal cramps, usually 12 to 72 hours after eating contaminated food. Most people recover without treatment, but severe cases can need hospital care.

Product as listed by the FDA

The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and genetic virulence markers from liquid or soft stool preserved in Cary-Blair media, collected from individuals with signs and symptoms of gastrointestinal infection. The test is performed on the automated Nanosphere Verigene System utilizing reverse transcription (RT), polymerase chain reaction (PCR), and array hybridization to detect specific gastrointestinal microbial nucleic acid gene sequences associated with the following pathogenic bacteria: - Campylobacter Group (comprised of C. coli, C. jejuni, and C. lari), - Salmonella species, - Shigella species (including S. dysenteriae, S. boydii, S. sonnei, and S. flexneri), - Vibrio Group (comprised of V. cholerae and V. parahaemolyticus), - Yersinia enterocolitica. In addition, EP detects the Shiga toxin 1 gene and Shiga toxin 2 gene virulence markers. Shiga toxin producing E. coli (STEC) typically harbor one or both genes that encode for Shiga Toxins 1 and 2. EP is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness, in conjunction with other clinical, laboratory, and epidemiological information; however, is not to be used to monitor these infections. EP also aids in the detection and identification of acute gastroenteritis in the context of outbreaks. Due to the limited number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Yersinia enterocolitica, Vibrio Group and Shigella species were primarily established with contrived specimens. Concomitant culture is necessary for organism recovery and further typing of bacterial agents. EP results should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Confirmed positive results do not rule out co-infection with other organisms that are not detected by this test, and may not be the sole or definitive cause of patient illness. Negative EP results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.

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.

Nationwide 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

Is The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test recalled?

Yes. Nanosphere recalled The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test on 10 Oct 2013. The recall is Class II and its status is Terminated. Recall number Z-2685-2014.

Why was it recalled?

Which lots are affected?

Product Number: (Not Applicable); Lot Numbers and Expiration Dates: 1) Lot: 091313023CIUO, Expiration Date: 03/12/14; 2) Lot 092713023CIUO, Expiration Date: 03/26/14

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

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-Positive Blood Culture Nucleic Acid Test recalled	Nanosphere	Listeria	Nationwide
1 Oct 2014Device	CLASS II	The Verigene Gram Negative Blood Culture Nucleic Acid Test recalled	Nanosphere	Other	Nationwide
1 Oct 2014Device	CLASS II	The Verigene Clostridium difficile Nucleic Acid Test recalled	Nanosphere	Botulism	Nationwide

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