The Recall Desk
ModerateFDA (Devices)·Z-2683-2014·Announced 2014-10-01

Nanosphere Recalls Verigene Gram-Positive Blood Culture Test Due to Processing Errors

Nanosphere is recalling 4,440 units of the Verigene Gram-Positive Blood Culture Nucleic Acid Test because Tip Holder Assemblies caused increased processing errors.

What this means for you

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, and the source text describes an increased rate of processing errors without reporting specific patient injuries or illnesses, fitting the criteria for a moderate severity recall involving potential for temporary or reversible health consequences.

Plain-English summary

Nanosphere, Inc. is recalling 4,440 units of the Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sample-to-result Verigene System. The recall is due to an increased rate of Processing Errors during procedures performed on the Processor SP, which were caused by Tips in Tip Holder Assemblies for specific lots of Extraction Trays.

The affected product is a qualitative, multiplexed in vitro diagnostic test used to detect and identify potentially pathogenic gram-positive bacteria in blood cultures. The recall covers specific lots with expiration dates ranging from March 5, 2014, to March 31, 2014. The product was distributed worldwide, including in the United States and internationally to Bulgaria, Germany, Italy, Japan, South Korea, and Spain.

Healthcare facilities and laboratories should stop using the affected lots and contact Nanosphere for instructions on returning the product. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
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
Manufacturer
Nanosphere, Inc.
Category
Medical Device — In Vitro Diagnostic
Hazard
Affected units
4,440

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 (13)

  • 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

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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