CLASS III Device recall · Reported 20 Aug 2014 · FDA Enforcement Report
Verigene Each CDF test consists of a Verigene CDF Nucleic recalled
Nanosphere is recalling Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a, distributed in California, Washington. The recall was initiated on 16 Oct 2013 and the FDA has classified it as Class III.
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-2168-2014
- FDA event ID
- 68708
- Recalling firm
- Nanosphere, Northbrook, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 16 Oct 2013
- FDA classified
- 8 Aug 2014
- Reported
- 20 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Botulism
- Device type
- Patient Monitors
Timeline
| 16 Oct 2013 | Recall initiated by company | |
| 8 Aug 2014 | Classified by FDA | +296 days |
| 20 Aug 2014 | Published in enforcement report | +12 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 report of an increased rate of "No Call - INT CTL 2" results for the Internal Control 2 (INT CTL 2) when negative samples are tested with certain lots of CDF Amplification Trays (20-011-022), which are contained in the CDF Amplification Reagent Kit (20-012-022); specifically for lots 061913022D and 071813022E.
Product as listed by the FDA
Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is by detection of the binary toxin (cdt) gene sequence and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the Verigene System and utilizes automated specimen preparation and polymerase chain reaction (PCR) amplification, combined with a nanoparticle-based array hybridization assay to detect the toxin gene sequences associated with toxin-producing C. difficile. The CDF test is indicated for use as an aid in the diagnosis of CDI. Detection of PCR ribotype 027 strains of C. difficile by the CDF test is solely for epidemiological purposes and is not intended to guide or monitor treatment for C. difficile infections. Concomitant culture is necessary only if further typing or organism recovery is required.
Where it was distributed
US Distribution including the states of CA and WA
Questions about this recall
Is Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene recalled?
Yes. Nanosphere recalled Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene on 16 Oct 2013. The recall is Class III and its status is Terminated. Recall number Z-2168-2014.
Why was it recalled?
Nanosphere has received report of an increased rate of "No Call - INT CTL 2" results for the Internal Control 2 (INT CTL 2) when negative samples are tested with certain lots of CDF Amplification Trays (20-011-022), which are contained in the CDF Amplification Reagent Kit (20-012-022); specifically for lots 061913022D and 071813022E.
Which lots are affected?
Verigene CDF Amplification Trays, Catalog Number: 20-011-022, Lot Numbers: 061913022D and 071813022E
Where was it sold?
US Distribution including the states of CA and WA
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 |
|---|---|---|---|---|---|
| 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 | Nationwide |
| Device | CLASS II | The Verigene Gram Negative Blood Culture Nucleic Acid Test recalled | Nanosphere | Other | Nationwide |
| Device | CLASS II | The Verigene Clostridium difficile Nucleic Acid Test recalled | Nanosphere | Botulism | Nationwide |
Other Patient Monitors recalls
All 1,012| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Device | CLASS II | Digital ECG HD+12, HD+15 recalled by Midmark | Midmark | Labeling Errors | Nationwide |