Nanosphere Verigene Enteric Pathogens Test Recalled for Processing Errors
Nanosphere is recalling 220 units of the Verigene Enteric Pathogens Nucleic Acid Test due to increased processing errors caused by Tip Holder Assemblies.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' severity score under the rubric, as it involves a product defect that could cause temporary or medically reversible health consequences.
Plain-English summary
Nanosphere, Inc. is recalling 220 units of the Verigene Enteric Pathogens Nucleic Acid Test (EP). The recall is due to reports of an increased rate of Processing Errors during procedures performed on the Processor SP. These errors are caused by Tips in Tip Holder Assemblies used with specific lots of Extraction Trays.
The affected product is a multiplexed, qualitative test used to detect and identify common pathogenic enteric bacteria and genetic virulence markers from stool samples. The recall covers two specific lots: Lot 091313023CIUO (Expiration Date: 03/12/14) and Lot 092713023CIUO (Expiration Date: 03/26/14). The products were distributed worldwide, including in the United States and internationally to Bulgaria, Germany, Italy, Japan, South Korea, and Spain.
The FDA has classified this as a Class II recall. Users should stop using the affected lots and contact Nanosphere, Inc. for further instructions or replacement.
The recalled product
- 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 indiv
- Manufacturer
- Nanosphere, Inc.
- Hazard
- Affected units
- 220
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 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
Distribution
Part of a larger recall action
This product is one of 5 recalled by Nanosphere, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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