Reported Jul 26, 2023 · Ongoing
Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box…
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?
- Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit
- REFMOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually
- pouch-sealed and labeled with REFMOL1452
- Lot codes and dates
- MOL1455 UDI-DI01-30816101025092
- MOL1455 kit lot codes
P17044NP17052NP17301NP17302NP17303NP17304NP17305NP17306NP17351NP17352NP17353NP17354NP17614NP17625NP17650NP17652NP17653NP17654NP17687N
- P17688N P17731N MOL1452 disc lot codes
P15886NP16794NP16795NP16796NP16883NP16885NP17022NP17056NP17057NP17047NP17023NP17176NP17177NP17294NP17178NP17295NP17359NP17362NP17296NP17361NP17046N
- Amount recalled
- 4,7878 units
Where it was sold
Why it was recalled
There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.
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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