Reported Jul 22, 2020 · Terminated
MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative…
DiaSorin Molecular LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DiaSorin Molecular LLC · 11331 Valley View St · Cypress, CA · 90630-5366
Is this the product you have?
- MOL3650
- Simplexa VZV Direct - Product Usageis 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)
- Lot codes and dates
- MOL3650 Simplexa VZV DirectLot Numbers Release Date Exp Date 5178N 06/12/19 6/30/2020 7004N 03/04/20 2/28/2021
- Amount recalled
- 405 plastic vials (24 vials per box)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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