Nanosphere Recalls Verigene Gram Negative Blood Culture Test Kits
Nanosphere is recalling 400 units of the Verigene Gram Negative Blood Culture Nucleic Acid Test due to an increased rate of processing errors caused by tip holder assemblies.
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 hazard involves processing errors rather than direct physical injury or high-risk pathogen exposure, fitting the criteria for a moderate severity score.
Plain-English summary
Nanosphere, Inc. is recalling 400 units of the Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN). This product is a qualitative multiplexed in vitro diagnostic test used to detect and identify selected gram-negative bacteria and resistance markers directly from blood culture media. The specific lot number is 100113021C, with an expiration date of 03/30/14.
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 associated with the affected Extraction Trays.
The affected products were distributed worldwide, including in the United States and internationally to Bulgaria, Germany, Italy, Japan, South Korea, and Spain. Users of the Verigene System should stop using the affected lots and contact Nanosphere for further instructions.
The recalled product
- Product
- 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 mark
- Manufacturer
- Nanosphere, Inc.
- Hazard
- Affected units
- 400
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: 20-009-021
- Lot Number and Expiration Date: Lot: 100113021C
- Expiration Date: 03/30/14
Distribution
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 →Related recalls
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