Nanosphere, Inc.: 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.

Agency Publication Date: September 23, 2014

Affected Products

Product: The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. BC-GN is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram negative bacteria as determined by gram st

Product Number: 20-009-021; Lot Number and Expiration Date: Lot: 100113021C, Expiration Date: 03/30/14

Lot Numbers:

Number

100113021C

Product: The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic strains Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is

Product Number: 20-009-022; Lot Number and Expiration Date: Lot: 100313022B, Expiration Date: 04/01/14

Lot Numbers:

Number

100313022B

Product: 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 a

Product Number: 20-009-018; Lot Numbers and Expiration Dates: 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

Lot Numbers:

Numbers

090613018B

091413018B

091713018C

091813018B

092113018C

100213018B

Product: The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection. The following virus types and subtypes are identified using the RV+: Influenza A, Influenza A subtype H1, Influenza A subtype H3, 2009 H1N1, Influenza B, Respiratory Syncyti

Product Number: 20-009-020; Lot Number and Expiration Date: Lot: 091113020B, Expiration Date: 03/10/14

Lot Numbers:

Number

091113020B

Product: The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and genetic virulence markers from liquid or soft stool preserved in Cary-Blair media, collected from individuals with signs and symptoms of gastrointestinal infection. The test is performed on the automated Nanosphere Verigene System utilizing reverse transcription (RT), polymerase chain reaction (PCR), and array hybridizati

Product Number: (Not Applicable); Lot Numbers and Expiration Dates: 1) Lot: 091313023CIUO, Expiration Date: 03/12/14; 2) Lot 092713023CIUO, Expiration Date: 03/26/14

Lot Numbers:

Numbers

091313023CIUO

092713023CIUO

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 69034

Status: Resolved

Manufacturer: Nanosphere, Inc.

Manufactured In: United States

Units Affected: 5 products (400 units; 80 units; 4,440 units; 780 units; 220 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product Number: 20-009-021; Lot Number and Expiration Date: Lot: 100113021C, Expiration Date: 03/30/14

Lot Numbers:

Number

100113021C

Product Number: 20-009-022; Lot Number and Expiration Date: Lot: 100313022B, Expiration Date: 04/01/14

Lot Numbers:

Number

100313022B

Lot Numbers:

Numbers

090613018B

091413018B

091713018C

091813018B

092113018C

100213018B

Product Number: 20-009-020; Lot Number and Expiration Date: Lot: 091113020B, Expiration Date: 03/10/14

Lot Numbers:

Number

091113020B

Product Number: (Not Applicable); Lot Numbers and Expiration Dates: 1) Lot: 091313023CIUO, Expiration Date: 03/12/14; 2) Lot 092713023CIUO, Expiration Date: 03/26/14

Lot Numbers:

Numbers

091313023CIUO

092713023CIUO