Nanosphere Verigene BC-GP Kit Extraction Tray Recall
Nanosphere is recalling Verigene BC-GP Kit extraction trays because a specific lot may cause processing errors and tips to drop into the processor.
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 describes a mechanical processing error rather than a direct patient safety hazard or reported injury, fitting the Moderate criteria for low-risk operational issues.
Plain-English summary
Nanosphere, Inc. is recalling 1,660 Verigene BC-GP Kit extraction trays (Part Number 20-009-018; Lot Numbers 051713018B, 052413018C). The product is a qualitative multiplexed in vitro diagnostic test used for the detection and identification of selected bacteria and resistance markers.
The recall is due to a specific extraction tray lot containing tips that may slightly increase the occurrence of Process SP Processing Errors. This issue occurs when the Processor SP experiences difficulty releasing the tip to its final location in the Tip Assembly. The difficulty in releasing the tip can result in a processing error and occasionally cause the tip to be 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 check their inventory for the specific lot numbers listed and contact Nanosphere, Inc. for instructions on how to return or dispose of the affected trays.
The recalled product
- Product
- Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP 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.
- Affected units
- 1,660
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)
- Part Number: 20-009-018
- Lot Numbers: 051713018B
- 052413018C
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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