DiaSorin Molecular LLC Recall 88825
Description: SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
DiaSorin Molecular LLC Recall 88825 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0162-2022 |
| Event ID | 88825 |
| Event Description | SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CO, DE, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NV, NY, OH, OK, PA, SD, TN, TX, VA, VT, WA, WI, WV and the countries of Canada, Italy. |
| Quantity | 1690 kits |
| Recall Reason | Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals. |
| Device Classification | 20211027 |
| Device Code Info | Lot #/Expiration Date: 12175N/11.30.2021, 12722N/01.31.2022, X12122N/01.31.2022, X12724N/08.31.2022 |
| Center Classification Date | 20211021 |
| Recall Initiation Date | 20210923 |
| Recalling Firm | DiaSorin Molecular LLC |
| Initial Notification | |
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