Recall Z-2153-2023— DiaSorin Molecular LLC
Class II · Ongoing
Class II FDA medical device recall by DiaSorin Molecular LLC, initiated 2023-06-14. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc..
- Recalling firm
- DiaSorin Molecular LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-06-14
- Firm location
- Cypress, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.