FDAFDA · Food and drugs·Recall number Z-2735-2014
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.
Published October 8, 2014 · Recall initiated: June 17, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Nanosphere, Inc.
- Distributor
- 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.
- Lot
- Part Number: 20-009-018; Lot Numbers: 051713018B, 052413018C
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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