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DiaSorin Molecular LLC FDA Recalls
5 recalls on file across devices, 0 of them Class I and 5 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 boClass IIJun 14, 2023There is a potential for the direct amplification disc to ma |
| Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition Class IIJan 30, 2023Direct amplification Discs , used with COVID-19 and Flu A/B |
| Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2Class IIJan 30, 2023Direct amplification Discs , used with COVID-19 and Flu A/B |
| Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455Class IINov 19, 2021A subset of affected discs are at risk of leakage when it is |
| SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051Class IISep 23, 2021Due to unapproved raw materials used in the manufacturing |