The Verigene Gram Negative Blood Culture Nucleic Acid Test — Class II medical device recall Z-2681-2014
Terminated recall by Nanosphere, Inc., reported 2014-10-01, distributed in AZ, CA, FL, GA, IA, IL, IN, KY…. Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures p
| Recall number | Z-2681-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nanosphere, Inc., Northbrook, IL, United States |
| Recall initiated | 2013-10-10 |
| Classified | 2014-09-23 |
| Reported by FDA | 2014-10-01 |
| Terminated | 2015-06-16 |
| Distributed | AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MN, MO, MT, NC, NE, NJ, NY, OH, OR, PA, TX, UT, VA, WA, WI |
| Countries outside the US | BG, DE, ES, IT, JP, KR |
| Quantity | 400 units |
| Lot numbers | 100113021C |
| Expiration dates | 2014-03-30 |
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 stain.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2681-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.