CLASS II Device recall · Reported 8 Oct 2014 · FDA Enforcement Report
Verigene Bc-gn Kit recalled by Nanosphere
Nanosphere is recalling Verigene Bc-gn Kit (, distributed nationwide in the US. The recall was initiated on 17 Jun 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2736-2014
- FDA event ID
- 68014
- Recalling firm
- Nanosphere, Northbrook, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jun 2013
- FDA classified
- 30 Sep 2014
- Reported
- 8 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 17 Jun 2013 | Recall initiated by company | |
| 30 Sep 2014 | Classified by FDA | +470 days |
| 8 Oct 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process SP Processing Error when used due to the Processor SP experiencing difficulty releasing the Tip to the final location in the Tip Assembly. The difficult releasing the Tip can result in a Processing Error and occasionally the Tip to be dropped into the Processor SP.
Product as listed by the FDA
Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers.
Where it was distributed
Worldwide Distribution:US (Nationwide) including states of: AZ, CA, FL, IL, KY, MD, MN, MT, OH, PA, TN, TX, VA, WA, WI; and countries of: Belgium, China, and Saudi Arabia.
Nationwide ArizonaCaliforniaFloridaIllinoisKentuckyMarylandMinnesotaMontanaOhioPennsylvaniaTennesseeTexasVirginiaWashingtonWisconsin
Questions about this recall
Is Verigene Bc-gn Kit ( recalled?
Yes. Nanosphere recalled Verigene Bc-gn Kit ( on 17 Jun 2013. The recall is Class II and its status is Terminated. Recall number Z-2736-2014.
Why was it recalled?
There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process SP Processing Error when used due to the Processor SP experiencing difficulty releasing the Tip to the final location in the Tip Assembly. The difficult releasing the Tip can result in a Processing Error and occasionally the Tip to be dropped into the Processor SP.
Which lots are affected?
Part Number: 20-009-021; Lot Numbers: 052113021C
Where was it sold?
Worldwide Distribution:US (Nationwide) including states of: AZ, CA, FL, IL, KY, MD, MN, MT, OH, PA, TN, TX, VA, WA, WI; and countries of: Belgium, China, and Saudi Arabia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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