MOL3655 Simplexa VZV Swab Direct - Product Usage: is recall: Software Issue
MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster…
Why was MOL3655 Simplexa VZV Swab Direct - Product Usage: is recalled?
Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
MOL3655 Simplexa VZV Swab Direct: 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
- Product
- MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster…
- Recalling firm
- DiaSorin Molecular LLC
- Quantity
- 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.
- Recall date
- July 22, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)