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U.S. Department of Health and Human Services

Class 2 Device Recall DASH SARSCoV2 & Flu A/B Test

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 Class 2 Device Recall DASH SARSCoV2 & Flu A/B Testsee related information
Date Initiated by FirmJune 25, 2025
Date PostedAugust 06, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2274-2025
Recall Event ID 97228
510(K)NumberK241652 
Product Classification Multi-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents - Product Code QOF
ProductDASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & Flu A/B Test is individually pouched and labeled. The tests are provided to users in quantities of 10 per kit. Used on the DASH instrument.
Code Information Lot Code: Lot: BB02 UDI: (01)00850063063036(17)260220(10)BB02 Expiration Date: 20 Feb. 2026 Lot Code: Lot: BB03 UDI: (01)00850063063036(17)260220(10)BB03 Expiration Date: 20 Feb. 2026
Recalling Firm/
Manufacturer		 Nuclein LLC
8305 Cross Park Dr
Austin TX 78754-5154
For Additional Information ContactCustomer Support
+1-888-9923274
Manufacturer Reason
for Recall		Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
FDA Determined
Cause 2		Process control
ActionOn June 25, 2025, Nuclein, LLC issued a Urgent: Medical Device Recall notification to affected customers. On July 8, 2025 an updated notification was issued via E.Mail. a. Review your inventory of DASH SARS-CoV-2 & Flu A/B Tests to confirm the quantity of Lot BB02 or BB03 that you have remaining. b. Suspend the use and quarantine the affected lot of DASH SARS-CoV-2 & Flu A/B Tests; Nuclein will replace any unused affected product. c. Review all results of the product lots detailed in Section 6, below, to identify potentially erroneous diagnosis, except in those cases where alternative confirmation was obtained. d. Forward this information to all individuals and departments within your organization using the product information detailed in Section 6. If you are not the end user, forward this notice to the product end user. e. Complete the Acknowledgement and Receipt Form below and either email the completed form to customersupport@nuclein.com or mail to the address identified in the Acknowledgement and Receipt Form. f. Return the affected tests that you have remaining; Nuclein Customer Support will follow up with you on the details of returning or destroying the affected product.
Quantity in Commerce710 units
DistributionUS distribution to: Florida, New York, Texas, and West Virginia
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = QOF
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