Z-0162-2022 Class II Ongoing
FDA device recall Z-0162-2022 was initiated by DiaSorin Molecular LLC on September 23, 2021 and is designated Class II. Reason for recall: Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals. The recall status is ongoing. Affected quantity: 1690 kits.
Recall Details
- Product Type
- Devices
- Report Date
- October 27, 2021
- Initiation Date
- September 23, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1690 kits
Product Description
SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
Reason for Recall
Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.
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.
Code Information
Lot #/Expiration Date: 12175N/11.30.2021, 12722N/01.31.2022, X12122N/01.31.2022, X12724N/08.31.2022