Recall Z-1209-2023— DiaSorin Molecular LLC
Class II · Ongoing
Class II FDA medical device recall by DiaSorin Molecular LLC, initiated 2023-01-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2. Reason: Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes..
- Recalling firm
- DiaSorin Molecular LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-01-30
- Firm location
- Cypress, CA, United States
Product description
Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2
Reason for recall
Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.
Data sourced from openFDA. This site is unofficial and independent of the FDA.