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U.S. Department of Health and Human Services

Class 2 Device Recall MOL2150 Simplexa HSV 1&2 Direct

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  Class 2 Device Recall MOL2150 Simplexa HSV 1&2 Direct see related information
Date Initiated by Firm May 12, 2020
Create Date July 10, 2020
Recall Status1 Open3, Classified
Recall Number Z-2547-2020
Recall Event ID 85744
510(K)Number K141458  K150962  
Product Classification Herpes simplex virus nucleic acid amplification assay - Product Code OQO
Product MOL2150 Simplexa HSV 1&2 Direct
-CSF
-Genital Swab
-Cutaneous / Mucocutaneous Swabs
Product Usage: is intended for use on the LIAISON¿ MDX instrument for the qualitative detection and differentiation of HSV-1 and HSV-2 present in cerebrospinal fluid (CSF), or cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of HSV-1 or HSV-2 infection of the central nervous system (CNS) or cutaneous and mucocutaneous lesions.
Code Information MOL2150 Simplexa HSV 1&2 Direct: o K141458 CSF 07/01/2014 o K150962 Genital Swab 08/28/2015 o K173798 Cutaneous / Mucocutaneous Swabs 03/14/2018  Lot Numbers Release Date Exp Date 3606N 08/16/18 6/30/2020 3607N 08/31/18 6/30/2020 3609N 08/31/18 6/30/2020 3610N 10/08/18 7/31/2020 3615N 01/07/19 6/30/2020 3616N 11/28/18 6/30/2020 3618N 12/26/18 6/30/2020 3619N 12/26/18 6/30/2020 3847N 12/31/18 6/30/2020 3998N 07/20/18 5/31/2020 4000N 07/18/18 5/31/2020 4130N 03/05/19 6/30/2020 4131N 02/01/19 6/30/2020 4132N 02/15/19 6/30/2020 4134N 04/18/19 8/31/2020 4137N 04/04/19 8/30/2020 4138N 04/30/19 8/31/2020 4139N 07/12/19 5/31/2021 5171N 09/17/19 6/30/2021 5172N 09/03/19 6/30/2021 5173N 05/03/19 8/31/2020 5174N 06/04/19 8/31/2020 5175N 06/04/19 8/31/2020 5187N 07/19/19 5/31/2021 5188N 06/05/19 8/31/2020 5189N 07/25/19 5/31/2021 5190N 05/23/19 8/31/2020 5623N 07/25/19 5/31/2021 5738N 08/02/19 5/31/2021 5739N 08/20/19 6/30/2021 5793N 10/07/19 7/31/2021 5795N 03/09/20 12/31/2021 5841N 10/22/19 8/31/2021 5843N 10/31/19 8/31/2021 5845N 10/18/19 8/31/2021 5846N 04/06/20 1/31/2022 5846NA 04/16/20 1/31/2022 5847N 12/17/19 10/31/2021 5878N 03/11/20 1/31/2022 5888N 03/18/20 1/31/2022 R5170N 06/20/19 8/31/2020 R5201N 06/28/19 8/31/2020 R5202N 07/03/19 4/30/2021 R5283N 08/13/19 8/31/2020 R5285N 06/20/19 8/31/2020  
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 13943 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 = OQO and Original Applicant = FOCUS DIAGNOSTICS
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