Reported Jan 12, 2022 · Ongoing
Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
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, Product Kit Code MOL1455
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 Lot numbers (and MOL1452 Disc 2 Lot Numbers): 12410N (12152N), 12411N (12147N), 12413N (12149N), 12477N (12150N), 12602N (11548NA), 12603N (12144N), 12721N (12148N), 12889N (12151N), 13369N (12817N), 13370N (13151N), 13434N (12382N), 13652N (12835N), and 13242N (12154N)*. *Kit 3 Lot #13242N (Disc 4 Lot #12154N) was shipped to Europe and not within the US. - Amount recalled
- 29495 kits
Where it was sold
Why it was recalled
A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well that had a positive sample may cause further cross-contamination in areas of the lab if not properly cleaned.
This product could cause temporary or reversible health problems — stop using it.
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