Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL1452
Reported: July 26, 2023 Initiated: June 14, 2023 #Z-2153-2023
Product Description
Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL1452
Reason for Recall
There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.
Details
- Recalling Firm
- DiaSorin Molecular LLC
- Units Affected
- 4,7878 units
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SD, TN, TX, VA, VT, WA, WI, WV and the countries of Bangladesh, Canada, Israel, Italy.
- Location
- Cypress, CA
Frequently Asked Questions
What product was recalled? ▼
Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL1452. Recalled by DiaSorin Molecular LLC. Units affected: 4,7878 units.
Why was this product recalled? ▼
There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 26, 2023. Severity: Moderate. Recall number: Z-2153-2023.
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