Simplexa Direct Amplification Disc Kit recalled for potential liquid spillage
DiaSorin Molecular is recalling the Simplexa Direct Amplification Disc Kit due to potential malfunction that could cause liquid to spill from the device.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a potential malfunction with risk of liquid spillage. Per the severity rubric, this qualifies as 'High'—a risk-of-harm product where injury has not yet been reported and no illnesses, injuries, or hospitalizations are mentioned in the source.
Plain-English summary
The Simplexa Direct Amplification Disc Kit (MOL1455), manufactured by DiaSorin Molecular LLC, is a prescription in vitro diagnostic medical device. Each kit contains three individually pouch-sealed Direct Amplification Discs (DADs).
DiaSorin Molecular LLC has issued a Class II recall of this product due to a potential malfunction of the Direct Amplification Disc that may result in spillage of liquid from the disc.
The affected kits have been distributed nationwide across the United States and internationally to Bangladesh, Canada, Israel, and Italy. Multiple lot codes for both the MOL1455 kits and MOL1452 discs are identified in the manufacturer's recall documentation.
The recalled product
- 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
- Manufacturer
- DiaSorin Molecular LLC
- Category
- Medical Device — Diagnostic Kit
- Affected units
- 47,878
Distribution
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