The Recall Desk

FDA (Devices) recall action 68014

Nanosphere, Inc. recalled 2 products on 2014-10-08

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2014-10-08
Critical
0
Units
1,680

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2014-10-08

    Nanosphere Recalls Verigene BC-GN Kits Due to Processing Error Risk

    Nanosphere is recalling Verigene BC-GN Kits because a specific lot of extraction trays may cause processing errors in the device.

    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.
    Category
    Distribution
    15 states
  • ModerateFDA (Devices)··2014-10-08

    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.

    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.
    Category
    Distribution
    15 states