Reported Oct 1, 2014 · Terminated
The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sample-to-result Verigene System…
Nanosphere, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nanosphere, Inc. · 4088 Commercial Ave · Northbrook, IL · 60062-1829
Is this the product you have?
- The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). BC-UP is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria. BC-UP detects and identifies the
- following bacterial genera and speciesStaphylococcus spp., Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Enterococcus faecalis, Enterococcus faecium, Streptococcus spp., Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus, group and Listeria spp. In addition, BC-UP detects the mnecA resistance marker, inferring mecA-mediated, methicillin resistance, and the vanA and vanB resistance markers, inferring vanA/vanB-mediated vancomycin resistance. In mixed growth, BC-UP does not specifically attribute van-mediated vancomycin resistance to either E. faecalis or E. faecium, or mecA-mediated methicillin resistance to either S. aureus or S. epidermidis. BC-UP is indicated for use in conjunction with other clinical and laboratory findings to, aid in the diagnosis of bacterial bloodstream infections; however, is not to be used to, monitor these infections. Sub-culturing of positive blood cultures is necessary to recover, organisms for susceptibility testing, identification of organisms not detected by BC-UP, differentiation of mixed growth, association of antimicrobial resistance marker genes to a specific organism, or for epidemiological typing
- Lot codes and dates
6 of 6 products
Products covered by this recall # Product as published 1 Lot: 090613018B, Expiration Date: 03/05/14 2 Lot: 091413018B, Expiration Date: 03/13/14 3 Lot: 091713018C, Expiration Date: 03/16/14 4 Lot: 091813018B, Expiration Date: 03/17/14 5 Lot: 092113018C, Expiration Date: 03/20/14 6 Lot: 100213018B, Expiration Date: 03/31/14 - Amount recalled
- 4,440 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays.
This product could cause temporary or reversible health problems — stop using it.
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