Simplexa Covid-19 Direct
Brand(s)
Summary
Discontinue using remaining inventory, share recall notice with users, complete/return response form.
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Simplexa Covid-19 Direct | 13967N 13968N 15061N 13330N 13331N 14016N 13336N | MOL4150 |
Issue
Customer complaints were received for disc leaks while running Simplexa Covid-19 Direct kit with assay definition version 2 (high spin & temp). Leakage was confirmed by retain testing on 1/6/22 with discs run on Covid-19 Direct assay definition version 2. No disc leakage occurred with version 3 (reduced spin & temp). Simplexa Flu A/B & RSV (mol2655) and Simplexa Covid-19 & Flu A/B Direct (mol4250) have similar assay definitions and are also at risk for leakage.
Recall start date: February 01, 2023
Additional information
Details
Diasorin Molecular LLC
11331 Valley View Street, Cypress, California, United States, 90630
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