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U.S. Department of Health and Human Services

Class 2 Device Recall MOL3655 Simplexa VZV Swab Direct

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  Class 2 Device Recall MOL3655 Simplexa VZV Swab Direct see related information
Date Initiated by Firm May 12, 2020
Create Date July 10, 2020
Recall Status1 Open3, Classified
Recall Number Z-2549-2020
Recall Event ID 85744
510(K)Number K192376  
Product Classification Herpes virus (VZV, HSV1, HSV2), DNA detection assay for cutaneous and mucocutaneous lesion samples - Product Code PGI
Product MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON¿ MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA present in cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of VZV infection.
Code Information MOL3655 Simplexa VZV Swab Direct: 510K# K192376 11/26/2019  Lot Numbers Release Date Exp Date 5743N 09/11/19 9/30/2020 5819N 10/09/19 10/31/2020 5820N 02/14/20 2/28/2021  
Recalling Firm/
Manufacturer
DiaSorin Molecular LLC
11331 Valley View St
Cypress CA 90630-5366
For Additional Information Contact
562-240-6500
Manufacturer Reason
for Recall
Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
FDA Determined
Cause 2
Under Investigation by firm
Action On 05/12/2020, the firm sent an "URGENT FIELD SAFETY NOTIFICATION LETTER" with an acknowledgement form to customers and distributors via email to inform them of an internal observed issue associated with the use of their Multi-Assay Suite (MAS) featured in the software version 2.0 where it may incorrectly apply the thresholds of the first loaded assay to the analytes coupled with the same dye in the second assay resulting in false negative or false positive results. The firm is instructing customers to: -Immediately discontinue the use of the MAS feature and that the issue will be correct in the new Software Version 2.1 which is expected to be release in June 2020. -Fill out the Response Form and return by either: -fax (562) 240-6526 Attention: Technical Services -email to: technical info.molecular@diasorin.com -mail to: ATTN: Technical Services, 11331 Valley View Street, Cypress, CA 90630 -Forward this communication to all required individuals with their organization. For further assistance with evaluating assay runs or for any questions, to contact Technical Services at +1-5672-240-6500, option 3 or via email ts.molecular@DiaSorin.com
Quantity in Commerce 304 plastic vials (24 vials per box)
Distribution Worldwide distribution - U.S. Nationwide distribution including in the states of CO, FL, KS, MI, NC, PA, TX, and WA The countries of Austria, Czech Republic, France and Switerland.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = PGI and Original Applicant = DiaSorin Molecular LLC
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