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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0162-2022
Event ID88825
Event DescriptionSIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
Product TypeDevices
DistributionWorldwide 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.
Quantity1690 kits
Recall ReasonDue to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.
Device Classification20211027
Device Code InfoLot #/Expiration Date: 12175N/11.30.2021, 12722N/01.31.2022, X12122N/01.31.2022, X12724N/08.31.2022
Center Classification Date20211021
Recall Initiation Date20210923
Recalling FirmDiaSorin Molecular LLC
Initial Notification E-Mail
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