Simplexa Direct Amplification Disc Kit
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected Products |
Lot or serial number |
Model or catalog number |
||
|---|---|---|---|---|
Simplexa Direct Amplification Disc Kit |
13652N |
MOL1455 |
||
Simplexa Direct Amplification Disc Kit |
13369N |
MOL1455 |
||
Simplexa Direct Amplification Disc Kit |
12603N |
MOL1455 |
||
Simplexa Direct Amplification Disc Kit |
12889N |
MOL1455 |
Issue
A recent internal investigation revealed that a subset of Simplexa Direct Amplification Discs (Ref MOL1455) are at risk of leakage when the disc is used more than one time with Simplexa Covid-19 direct and/or Simplexa flu A/B & RSV Direct Gen II. The predicted risk of leakage has been determined to be very low (0.0045%)
Recall start date: Nov 19, 2021
Additional information
Details
| Diasorin Molecular LLC |
|
11331 Valley View Street, Cypress, California United States, 90630 |
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