The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2684-2014·Announced 2014-10-01

Nanosphere Recalls Verigene Respiratory Virus Plus Test Due to Processing Errors

Nanosphere is recalling Verigene Respiratory Virus Plus tests because Tip Holder Assemblies caused increased processing errors on the Processor SP.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity recall involving a functional defect without reported harm.

Plain-English summary

Nanosphere, Inc. is recalling 780 units of the Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System. The recall involves Product Number 20-009-020, specifically Lot 091113020B with an expiration date of 03/10/14. The affected units were distributed worldwide, including in the United States and in Bulgaria, Germany, Italy, Japan, South Korea, and Spain.

The recall was initiated after Nanosphere received several reports of an increased rate of Processing Errors during procedures performed on the Processor SP. These errors were caused by Tips in Tip Holder Assemblies used with the affected lots of Extraction Trays. The Verigene RV+ is a qualitative nucleic acid multiplex test intended to detect and identify multiple respiratory virus nucleic acids in nasopharyngeal swab specimens.

Healthcare facilities and laboratories that possess the affected product should stop using it and contact Nanosphere for instructions on return or replacement. The source text does not report any specific illnesses or injuries resulting from the processing errors.

The recalled product

Product
The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with…
Manufacturer
Nanosphere, Inc.
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
780

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Product Number: 20-009-020
  • Lot Number and Expiration Date: Lot: 091113020B
  • Expiration Date: 03/10/14

Distribution

Distributed in 25 states:

Part of a larger recall action

This product is one of 5 recalled by Nanosphere, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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