| | Class 2 Device Recall DASH Rapid PCR Instrument |  |
| Date Initiated by Firm | October 22, 2025 |
|---|
| Date Posted | September 14, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-3164-2026 |
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| Recall Event ID |
99356 |
| 510(K)Number | K241652 |
|---|
| Product Classification |
Instrumentation for clinical multiplex test systems - Product Code NSU
|
| Product | Brand Name: DASH Rapid PCR Instrument
Product Name: DASH Rapid PCR Instrument
Model/Catalog Number: SG-0002
Software Version: 6.0.2, 6.0.4, 6.0.5, 6.0.6
Product Description: The DASH Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase chain reaction (RT-PCR) instrument that extracts specimens and performs nucleic acid amplified tests (NAAT) in DASH test cartridges for the qualitative detection of infectious diseases. The DASH Instrument is intended for use in conjunction with DASH Rapid PCR System tests to aid in the diagnosis of infectious diseases.
Component: No. |
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| Code Information |
Instrument Serial Numbers / UDI codes:
C01250001 (01)00850063063005(11)250217(21)C01250001
C01250003 (01)00850063063005(11)250217(21)C01250003
C01250004 (01)00850063063005(11)250214(21)C01250004
C01250005 (01)00850063063005(11)250214(21)C01250005
C01250006 (01)00850063063005(11)250218(21)C01250006
C01250007 (01)00850063063005(11)250218(21)C01250007
C01250008 (01)00850063063005(11)250218(21)C01250008
C01250009 (01)00850063063005(11)250218(21)C01250009
C01250010 (01)00850063063005(11)250218(21)C01250010
C02250002 (01)00850063063005(11)250221(21)C02250002
C02250003 (01)00850063063005(11)250221(21)C02250003
C02250004 (01)00850063063005(11)250221(21)C02250004
C02250005 (01)00850063063005(11)250221(21)C02250005
C02250007 (01)00850063063005(11)250225(21)C02250007
C02250008 (01)00850063063005(11)250307(21)C02250008
C02250009 (01)00850063063005(11)250225(21)C02250009
C02250010 (01)00850063063005(11)250225(21)C02250010
C02250011 (01)00850063063005(11)250227(21)C02250011
C02250012 (01)00850063063005(11)250227(21)C02250012
C02250014 (01)00850063063005(11)250227(21)C02250014
C02250015 (01)00850063063005(11)250227(21)C02250015
C02250016 (01)00850063063005(11)250307(21)C02250016
C02250018 (01)00850063063005(11)250310(21)C02250018
C02250019 (01)00850063063005(11)250311(21)C02250019
C02250020 (01)00850063063005(11)250311(21)C02250020
C03250002 (01)00850063063005(11)250627(21)C03250002
C03250003 (01)00850063063005(11)250403(21)C03250003
C03250004 (01)00850063063005(11)250404(21)C03250004
C03250005 (01)00850063063005(11)250408(21)C03250005
C03250006 (01)00850063063005(11)250319(21)C03250006
C03250007 (01)00850063063005(11)250319(21)C03250007
C03250008 (01)00850063063005(11)250512(21)C03250008
C03250009 (01)00850063063005(11)250415(21)C03250009
C03250012 (01)00850063063005(11)250417(21)C03250012
C03250013 (01)00850063063005(11)250408(21)C03250013
C03250015 (01)00850063063005(11)250421(21)C03250015
C03250016 (01)00850063063005(11)250417(21)C03250016
C03250018 (01)00850063063005(11)250421(21)C03250018
C03250019 (01)00850063063005(11)250421(21)C03250019
C03250020 (01)00850063063005(11)250423(21)C03250020
C04250003 (01)00850063063005(11)250509(21)C04250003
C04250004 (01)00850063063005(11)250421(21)C04250004
C04250005 (01)00850063063005(11)250509(21)C04250005
C05250006 (01)00850063063005(11)250512(21)C05250006
C05250007 (01)00850063063005(11)250513(21)C05250007
C05250008 (01)00850063063005(11)250513(21)C05250008
C05250010 (01)00850063063005(11)250512(21)C05250010
C05250011 (01)00850063063005(11)250514(21)C05250011
C05250012 (01)00850063063005(11)250514(21)C05250012
C05250013 (01)00850063063005(11)250514(21)C05250013
C05250016 (01)00850063063005(11)250520(21)C05250016
C05250017 (01)00850063063005(11)250520(21)C05250017
C05250021 (01)00850063063005(11)250521(21)C05250021
C05250022 (01)00850063063005(11)250520(21)C05250022
C05250024 (01)00850063063005(11)250520(21)C05250024
C05250026 (01)00850063063005(11)250605(21)C05250026
C05250028 (01)00850063063005(11)250509(21)C04250028
C05250029 (01)00850063063005(11)250605(21)C05250029
C05250030 (01)00850063063005(11)250606(21)C05250030
C05250031 (01)00850063063005(11)250605(21)C05250031
C05250033 (01)00850063063005(11)250609(21)C05250033
C05250034 (01)00850063063005(11)250609(21)C05250034
C05250035 (01)00850063063005(11)250609(21)C05250035
C05250036 (01)00850063063005(11)250609(21)C05250036
C05250039 (01)00850063063005(11)250606(21)C05250039
C05250040 (01)00850063063005(11)250609(21)C05250040
C05250042 (01)00850063063005(11)250610(21)C05250042
C06250001 (01)00850063063005(11)250610(21)C06250001
C06250002 (01)00850063063005(11)250610(21)C06250002
C06250003 (01)00850063063005(11)250610(21)C06250003
C06250005 (01)00850063063005(11)250611(21)C06250005
C06250006 (01)00850063063005(11)250611(21)C06250006
C06250008 (01)00850063063005(11)250611(21)C06250008
C06250010 (01)00850063063005(11)250611(21)C06250010
C06250012 (01)00850063063005(11)250624(21)C06250012
C06250013 (01)00850063063005(11)250623(21)C06250013
C06250015 (01)00850063063005(11)250623(21)C06250015
C06250016 (01)00850063063005(11)250623(21)C06250016
C06250017 (01)00850063063005(11)250624(21)C06250017
C06250019 (01)00850063063005(11)250623(21)C06250019
C06250020 (01)00850063063005(11)250624(21)C06250020
C06250022 (01)00850063063005(11)250624(21)C06250022
C06250023 (01)00850063063005(11)250624(21)C06250023
C06250024 (01)00850063063005(11)250624(21)C06250024
C06250025 (01)00850063063005(11)250625(21)C06250025
C06250026 (01)00850063063005(11)250624(21)C06250026
C06250027 (01)00850063063005(11)250625(21)C06250027
C06250028 (01)00850063063005(11)250625(21)C06250028
C06250029 (01)00850063063005(11)250625(21)C06250029
C06250030 (01)00850063063005(11)250626(21)C06250030
C06250032 (01)00850063063005(11)250626(21)C06250032
C06250033 (01)00850063063005(11)250627(21)C06250033
C06250034 (01)00850063063005(11)250627(21)C06250034
C06250035 (01)00850063063005(11)250627(21)C06250035
C06250036 (01)00850063063005(11)250630(21)C06250036
C06250037 (01)00850063063005(11)250701(21)C06250037
C06250039 (01)00850063063005(11)250630(21)C06250039
C06250040 (01)00850063063005(11)250702(21)C06250040
C06250041 (01)00850063063005(11)250702(21)C06250041
C06250042 (01)00850063063005(11)250702(21)C06250042
C06250043 (01)00850063063005(11)250703(21)C06250043
C06250047 (01)00850063063005(11)250707(21)C06250047
C06250048 (01)00850063063005(11)250625(21)C06250048
C06250049 (01)00850063063005(11)250707(21)C05250049
C06250050 (01)00850063063005(11)250708(21)C06250050
C06250051 (01)00850063063005(11)250707(21)C06250051
C07250003 (01)00850063063005(11)250710(21)C07250003
C07250005 (01)00850063063005(11)250710(21)C07250005
C07250006 (01)00850063063005(11)250710(21)C07250006
C07250007 (01)00850063063005(11)250715(21)C07250007
C07250008 (01)00850063063005(11)250714(21)C07250008
C07250010 (01)00850063063005(11)250714(21)C07250010
C07250011 (01)00850063063005(11)250714(21)C07250011
C07250013 (01)00850063063005(11)250715(21)C07250013
C07250014 (01)00850063063005(11)250716(21)C07250014
C07250016 (01)00850063063005(11)250715(21)C07250016
C07250017 (01)00850063063005(11)250715(21)C07250017
C07250018 (01)00850063063005(11)250725(21)C07250018
C07250019 (01)00850063063005(11)250725(21)C07250019
C07250020 (01)00850063063005(11)250725(21)C07250020
C07250021 (01)00850063063005(11)250725(21)C07250021
C07250023 (01)00850063063005(11)250725(21)C07250023
C07250024 (01)00850063063005(11)250725(21)C07250024
C07250027 (01)00850063063005(11)250725(21)C07250027
C07250032 (01)00850063063005(11)250728(21)C07250032
C07250033 (01)00850063063005(11)250729(21)C07250033
C07250036 (01)00850063063005(11)250729(21)C07250036
C07250037 (01)00850063063005(11)250729(21)C07250037
C07250038 (01)00850063063005(11)250624(21)C07250038
C07250039 (01)00850063063005(11)250729(21)C07250039
C07250040 (01)00850063063005(11)250730(21)C07250040
C07250041 (01)00850063063005(11)250729(21)C07250041
C07250042 (01)00850063063005(11)250729(21)C07250042
C07250043 (01)00850063063005(11)250730(21)C07250043
C07250044 (01)00850063063005(11)250731(21)C07250044
C07250045 (01)00850063063005(11)250731(21)C07250045
C07250047 (01)00850063063005(11)250731(21)C07250047
C07250048 (01)00850063063005(11)250801(21)C07250048
C07250050 (01)00850063063005(11)250731(21)C07250050
C07250051 (01)00850063063005(11)250801(21)C07250051
C07250052 (01)00850063063005(11)250801(21)C07250052
C07250053 (01)00850063063005(11)250804(21)C07250053
C07250055 (01)00850063063005(11)250804(21)C07250055
C07250056 (01)00850063063005(11)250805(21)C07250056
C07250057 (01)00850063063005(11)250804(21)C07250057
C07250058 (01)00850063063005(11)250805(21)C07250058
C07250059 (01)00850063063005(11)250805(21)C07250059
C07250060 (01)00850063063005(11)250805(21)C07250060
C07250061 (01)00850063063005(11)250805(21)C07250061
C08250003 (01)00850063063005(11)250805(21)C08250003
C08250005 (01)00850063063005(11)250806(21)C08250005
C08250008 (01)00850063063005(11)250813(21)C08250008
C08250009 (01)00850063063005(11)250807(21)C08250009
C08250010 (01)00850063063005(11)250808(21)C08250010
C08250011 (01)00850063063005(11)250815(21)C08250011
C08250016 (01)00850063063005(11)250813(21)C08250016
C08250019 (01)00850063063005(11)250815(21)C08250019
C08250025 (01)00850063063005(11)250818(21)C08250025
C08250027 (01)00850063063005(11)250818(21)C08250027
C08250039 (01)00850063063005(11)250821(21)C08250039
C08250041 (01)00850063063005(11)250822(21)C08250041
C08250042 (01)00850063063005(11)250822(21)C08250042
C08250044 (01)00850063063005(11)250825(21)C08250044
C08250045 (01)00850063063005(11)250825(21)C08250045
C08250046 (01)00850063063005(11)250825(21)C08250046
C08250049 (01)00850063063005(11)250826(21)C08250049
C08250050 (01)00850063063005(11)250826(21)C08250050
C08250052 (01)00850063063005(11)250827(21)C08250052
C08250054 (01)00850063063005(11)250902(21)C08250054
C08250056 (01)00850063063005(11)250904(21)C08250056
C08250057 (01)00850063063005(11)250905(21)C08250057
C08250059 (01)00850063063005(11)250909(21)C08250059
C08250061 (01)00850063063005(11)250903(21)C08250061
C08250063 (01)00850063063005(11)250908(21)C08250063
C08250065 (01)00850063063005(11)250909(21)C08250065
C08250071 (01)00850063063005(11)250915(21)C08250071
C08250073 (01)00850063063005(11)250917(21)C08250073
C08250074 (01)00850063063005(11)250916(21)C08250074
C08250075 (01)00850063063005(11)250917(21)C08250075
C08250076 (01)00850063063005(11)250915(21)C08250076
C08250077 (01)00850063063005(11)250917(21)C08250077
C08250078 (01)00850063063005(11)250917(21)C08250078
|
| FEI Number |
3014515702
|
Recalling Firm/
Manufacturer |
Nuclein LLC
8305 Cross Park Dr
Austin
TX
78754-5154
|
| For Additional Information Contact | Customer Support
+1-888-9923274 |
|---|
Manufacturer Reason
for Recall | Due to a software issue |
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FDA Determined
Cause 2 | Process control |
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| Action | On 10/22/2025 a "Customer Advisory Notification" via email to customers informing them of a software update to deal with potential of aborted test runs due to Error Code 0x25000012 (Pressure wet filter error).
Customer were informed that an over-the-air software update will automatically be available when the DASH Instrument is connected to the internet.
For questions or assistance - Nuclein Customer Support at 1-888-992-DASH (3274) or customersupport@nuclein.com
On 07/30/2026, an updated "URGENT: MEDICAL DEVICE CORRECTION" Letter was email to customers. The updated letter informed customer of the potential issues associated with the software issue that was not addressed in the initial letter sent on 10/22/2025. |
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| Quantity in Commerce | 182 |
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| Distribution | US Nationwide distribution in the states of Alabama, Delaware, Florida, Georgia, Kansas, Massachusetts, , Maryland, Maine, Michigan, North Carolina, New York, Ohio, South Carolina, Tennessee, Texas, Virginia, Vermont. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = NSU
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