Verigene BC-GN Test Kit (Catalog number 20-005-021)… recallZ-2236-2014 · Nanosphere, Inc. · initiated Jul 9, 2014
Class II Terminated All recalls posted in August 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
Nanosphere Inc. has recently determined through four customer complaints that a small number of Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) Extraction Trays in Lot 042914021B have low levels or are missing Magnetic Microparticles (MMPs) required for DNA Extraction.
FDA root cause category: Under Investigation by firm
What the company is doing
Nanosphere sent an Urgent Product Recall letter dated July 9, 2014 to all affected customers. All customers were initially notified of the recall by telephone on July 9, 2014. The customers were instructed to quarantine and return all affected product to Nanosphere. The letter included instructions: 1) on how to return the recalled products, and 2) to review any test results that were generated while using the recalled products to ensure that there has been no negative impact on patient care. Customers with questions were instructed to contact Nanosphere at 888-837-4436, option 2 or via e-mail at [email protected].
Recall details
- Recall number
- Z-2236-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 9, 2014
- Posted by the FDA
- Aug 14, 2014
- Recalling firm
- Nanosphere, Inc.
- Quantity
- 1045 extraction trays (840 affected by recall)
- Product code
- PEN
- FDA submissions
- K132843
- Distribution
- Nationwide Distribution including CA, CO, IA, MT, OH, OK, OR, TX, and UT
Product description
Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions, including wash solutions, oligonucleotide probe solution and signal amplification solutions required to generate a test result. BC-GN is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, is not used to monitor these infections.
Code information (models, lots, serial numbers)
VERIGENE BC-GN TEST KIT (Catalog Number: 20-005-021). TEST CARTRIDGES: Part Number: 20-006-021, Lot Number: 042914021B, Expiration Date: 10/26/14
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.
How recalls are matched to devices · Editorial policy · Report an error on this page