Reported Oct 27, 2021 · Ongoing
SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
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 COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only
- UDI(01) 20816101027051
- Lot codes and dates
- Lot #/Expiration
- Date
12175N/11.30.202112722N/01.31.2022X12122N/01.31.2022X12724N/08.31.2022
- Amount recalled
- 1690 kits
Where it was sold
Why it was recalled
Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.
This product could cause temporary or reversible health problems — stop using it.
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