Verigene BC-GN Kit — Class II medical device recall Z-2736-2014
Terminated recall by Nanosphere, Inc., reported 2014-10-08, distributed nationwide. There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process S
| Recall number | Z-2736-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nanosphere, Inc., Northbrook, IL, United States |
| Recall initiated | 2013-06-17 |
| Classified | 2014-09-30 |
| Reported by FDA | 2014-10-08 |
| Terminated | 2016-03-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CN, SA |
| Quantity | 20 extraction |
| Lot numbers | 052113021C |
| Model numbers | 20-005-021, 20-009-021 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2736-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.