Recall Z-2548-2020
DiaSorin Molecular LLC · initiated May 12, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA in cerebrospinal fluid (CSF) from patients with signs and symptoms of VZV infections of the central nervous system (CNS).
Codes / lots: MOL3650 Simplexa VZV Direct: Lot Numbers Release Date Exp Date 5178N 06/12/19 6/30/2020 7004N 03/04/20 2/28/2021
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: Under Investigation by firm
Action taken
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
Details
- Recall number
- Z-2548-2020
- Initiated
- May 12, 2020
- Posted by FDA
- July 10, 2020
- Terminated
- April 19, 2024
- Product code
- PLO – Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
- Quantity
- 405 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.
- Recalling firm
- DiaSorin Molecular LLC, Cypress, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2547-2020 Class II | MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs…Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of… | 05/12/2020Terminated |
| Z-2549-2020 Class II | MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX…Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of… | 05/12/2020Terminated |