Nanosphere Recalls Verigene Gram-Negative Blood Culture Test Cartridges
Nanosphere is voluntarily recalling Verigene Gram-Negative Blood Culture Test Cartridges due to an elevated risk of No Call and False Negative results.
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 is a voluntary precautionary recall addressing a risk of false negative results without reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
Nanosphere, Inc. has initiated a voluntary recall of Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) Cartridges. The recall affects 580 test cartridges from Lot Number 040214021A, which are distributed as part of the Verigene BC-GN Test Kit (Catalog Number: 20-005-021). The affected cartridges have an expiration date of 9/29/14 and are identified by Cartridge Numbers 02148613 through 02148832.
The recall was initiated because Nanosphere determined that a portion of the affected lot has an elevated risk for "No Call" results and False Negative results. The BC-GN test is a qualitative multiplexed in vitro diagnostic test used to detect and identify selected gram-negative bacteria and resistance markers in blood culture media. It is intended to aid in the diagnosis of bacterial bloodstream infections when used in conjunction with other clinical and laboratory findings.
The affected products were distributed in the United States, including the states of Arizona, California, Florida, Minnesota, Montana, Nebraska, New Jersey, New York, Texas, and Wisconsin. Users of the Verigene System should check their inventory for cartridges matching the specific lot and cartridge numbers listed above and stop using them immediately.
The recalled product
- Product
- 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 markers.
- Manufacturer
- Nanosphere, Inc.
- Affected units
- 580
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)
- Lot Number: 040214021A
- Cartridge Numbers: 02148613 - 02148832
- Expiration Date: 9/29/14
Distribution
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