Device product
SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
Z-0162-2022
Product summary
- Event
- Event 88825
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1690 kits
- Official record key
device-enforcement:Z-0162-2022
Official wording
Reason: Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.
Code information: Lot #/Expiration Date: 12175N/11.30.2021, 12722N/01.31.2022, X12122N/01.31.2022, X12724N/08.31.2022
Distribution pattern: 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.
Derived failure modes
-
Unknown
Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.