Nanosphere Recalls Verigene BC-GN Kits Due to Processing Error Risk
Nanosphere is recalling Verigene BC-GN Kits because a specific lot of extraction trays may cause processing errors in the device.
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. The hazard involves a mechanical processing error that may affect test performance, but the source text does not report any injuries, illnesses, or deaths.
Plain-English summary
Nanosphere, Inc. is recalling the Verigene BC-GN Kit (Catalog number 20-005-021), which contains 20 Verigene BC-GN Test Cartridges. These are qualitative multiplexed in vitro diagnostic tests used for the simultaneous detection and identification of selected gram-positive and gram-negative bacteria and resistance markers.
The recall is limited to a specific lot of extraction trays (Part Number: 20-009-021; Lot Number: 052113021C). The issue involves tips that may slightly increase the occurrence of a Process SP Processing Error. This occurs when the Processor SP experiences difficulty releasing the tip to its final location in the Tip Assembly, which can result in the tip being dropped into the Processor SP.
The affected products were distributed worldwide, including nationwide in the United States and in Belgium, China, and Saudi Arabia. Users should stop using the affected extraction trays and contact Nanosphere, Inc. for further instructions.
The recalled product
- Product
- Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers.
- Manufacturer
- Nanosphere, Inc.
- Hazard
- Affected units
- 20
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 (2)
- Part Number: 20-009-021
- Lot Numbers: 052113021C
Distribution
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
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