Nanosphere Recalls Verigene Clostridium difficile Test Due to Processing Errors
Nanosphere is recalling 80 units of the Verigene Clostridium difficile Nucleic Acid Test due to increased processing errors caused by Tip Holder Assemblies.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional defect (processing errors) without reporting any patient injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Nanosphere, Inc. is recalling 80 units of the Verigene Clostridium difficile Nucleic Acid Test (CDF). The affected product is identified by Product Number 20-009-022, Lot Number 100313022B, and an expiration date of 04/01/14.
The recall was initiated after Nanosphere received several reports of an increased rate of Processing Errors during procedures performed on the Processor SP. These errors were caused by Tips in Tip Holder Assemblies used with the affected Extraction Trays.
The affected units were distributed worldwide, including in the United States and internationally to Bulgaria, Germany, Italy, Japan, South Korea, and Spain. Users of the Verigene System should stop using the affected lots and contact Nanosphere for further instructions.
The recalled product
- 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 PC
- Manufacturer
- Nanosphere, Inc.
- Hazard
- Affected units
- 80
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 (3)
- Product Number: 20-009-022
- Lot Number and Expiration Date: Lot: 100313022B
- Expiration Date: 04/01/14
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.
See all 5 products in this recall →Related recalls
Same manufacturer · Nanosphere, Inc.
See all →- ModerateNanosphere Verigene BC-GP Kit Extraction Tray Recall
FDA (Devices) · 2014-10-08
- ModerateNanosphere Recalls Verigene BC-GN Kits Due to Processing Error Risk
FDA (Devices) · 2014-10-08
- SevereNanosphere Verigene Enteric Pathogens Test Recalled for Processing Errors
FDA (Devices) · 2014-10-01
- ModerateNanosphere Recalls Verigene Gram Negative Blood Culture Test Kits
FDA (Devices) · 2014-10-01
- ModerateNanosphere Recalls Verigene Respiratory Virus Plus Test Due to Processing Errors
FDA (Devices) · 2014-10-01
Same hazard · processing error
See all →- ModerateArthrex Recalls Tibial Opening Wedge Osteotomy Plates Due to Processing Error
FDA (Devices) · 2021-04-21
- HighMayer Brothers Recalls Apple Cider Due to Pasteurization Error
FDA (Food) · 2020-11-25
- HighKroger Recalls Lupron Depot Due to Lack of Processing Controls
FDA (Drugs) · 2018-05-16
- SevereMonster Energy Recalls Java Monster Loco Moca Coffee Due to Processing Error
FDA (Food) · 2017-09-20
- ModerateBioMérieux Recalls VITEK 2 Compact 30 Software and Reagent Cards
FDA (Devices) · 2017-09-06