SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
Reported: October 27, 2021 Initiated: September 23, 2021 #Z-0162-2022
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.
Details
- Recalling Firm
- DiaSorin Molecular LLC
- Units Affected
- 1690 kits
- 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.
- Location
- Cypress, CA
Frequently Asked Questions
What product was recalled? ▼
SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051. Recalled by DiaSorin Molecular LLC. Units affected: 1690 kits.
Why was this product recalled? ▼
Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 27, 2021. Severity: Moderate. Recall number: Z-0162-2022.
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