FDA Device recall Z-2736-2014
Verigene BC-GN Kit (Catalog number 20-005-021)
- FDA Device
- Class II
- terminated
- Published 2014-10-08
On 2014-10-08 the FDA classified a Class II recall of Verigene BC-GN Kit (Catalog number 20-005-021) by Nanosphere, citing 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 dif….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2736-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-17 |
| Published | 2014-10-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Nanosphere |
| Distribution | US |
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
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.
Identifiers
| code_info | Part Number: 20-009-021; Lot Numbers: 052113021C |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2736-2014%22
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