Simplexa Direct Amplification Disc Kit
Brand(s)
Summary
Review notice & return reply form, discard remaining inventory, and retest any sample with an error code.
Affected products
Affected prodcuts |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Simplexa Direct Amplification Disc Kit |
More than 10 numbers, contact manufacturer. |
MOL1455 |
Issue
A recent internal investigation identified a specific set of Simplexa Direct Amplification Discs (Mol1455) lots produced with a specific lot of raw material are at potential risk of leaking when the disc is re-used multiple times with the assays Simplexa HSV 1&2 Direct Mol2150, Simplexa Bordetella Direct (Mol2750), and Simplexa VZV Direct (Mol3650). A total of 13 affected lots of Mol1455 were shipped and distributed in Canada. A total 15 customers running these assays have the affected disc lots.
Recall start date: June 26, 2023
Additional information
Details
| Diasorin Molecular Llc |
| 11331 Valley View Street, Cypress, California, United States, 90630 |
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