Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Ki...
FDA Device Recall #Z-2153-2023 — Class II — June 14, 2023
Recall Summary
| Recall Number | Z-2153-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 14, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | DiaSorin Molecular LLC |
| Location | Cypress, CA |
| Product Type | Devices |
| Quantity | 4,7878 units |
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.
Distribution Pattern
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.
Lot / Code Information
MOL1455 UDI-DI: 01-30816101025092 MOL1455 kit lot codes: P17044N P17052N P17301N P17302N P17303N P17304N P17305N P17306N P17351N P17352N P17353N P17354N P17614N P17625N P17650N P17652N P17653N P17654N P17687N P17688N P17731N MOL1452 disc lot codes: P15886N P16794N P16795N P16796N P16883N P16885N P17022N P17056N P17057N P17047N P17023N P17176N P17177N P17294N P17178N P17295N P17359N P17362N P17296N P17361N P17046N
Other Recalls from DiaSorin Molecular LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1209-2023 | Class II | Simplexa COVID-19 Direct, REF: MOL4150; includi... | Jan 30, 2023 |
| Z-1210-2023 | Class II | Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2... | Jan 30, 2023 |
| Z-0457-2022 | Class II | Simplexa Direct Amplification Disc Kit, Product... | Nov 19, 2021 |
| Z-0162-2022 | Class II | SIMPLEXA COVID-19 Positive Control Pack, REF MO... | Sep 23, 2021 |
| Z-2549-2020 | Class II | MOL3655 Simplexa VZV Swab Direct - Product Usag... | May 12, 2020 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.