Verigene BC-GN Kit (Catalog number 20-005-021) recallZ-2736-2014 · Nanosphere, Inc. · initiated Jun 17, 2013
Class II Terminated All recalls posted in September 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Nanosphere, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process SP Processing Error when used due to the Processor SP experiencing difficulty releasing the Tip to the final location in the Tip Assembly. The difficult releasing the Tip can result in a Processing Error and occasionally the Tip to be dropped into the Processor SP.
FDA root cause category: Process change control
What the company is doing
Undated recall notification letters were sent to all direct accounts (customers) June 17 - 19, 2013. The letters included instructions for customers to: 1) check their inventory for the recalled products; 2) set any recalled products aside for return; and, 3) contact Nanosphere to obtain replacement tip holders. Customers with questions about this recall can contact Nanosphere via e-mail at [email protected] or by calling 888-837-4436.
Recall details
- Recall number
- Z-2736-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 17, 2013
- Posted by the FDA
- Sep 30, 2014
- Recalling firm
- Nanosphere, Inc.
- Quantity
- 20 extraction trays
- Product code
- PEN
- FDA submissions
- K132843
- Distribution
- Worldwide Distribution:US (Nationwide) including states of: AZ, CA, FL, IL, KY, MD, MN, MT, OH, PA, TN, TX, VA, WA, WI; and countries of: Belgium, China, and Saudi Arabia.
Product description
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.
Code information (models, lots, serial numbers)
Part Number: 20-009-021; Lot Numbers: 052113021C
Other devices under the same FDA submission
3 devices cleared under K132843 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Gram-Negative Blood Culture (BC-GN) Nucleic Acid Test Cartridge 20-006-021Luminex Corporation · Gram-Negative bacteria and associated resistance markers1 recall1 death15 reports
- Gram-Negative Blood Culture (BC-GN) Nucleic Acid Test Cartridge 20-006-021Nanosphere, Inc. · Gram-Negative Bacteria And Associated Resistance Markers2 deaths2 reports
- Gram-Negative Blood Culture (BC-GN) Utility Tray 20-011-021Luminex Corporation · Gram-Negative bacteria and associated resistance markers1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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