Recall Z-0162-2022— DiaSorin Molecular LLC
Class II · Ongoing
Class II FDA medical device recall by DiaSorin Molecular LLC, initiated 2021-09-23. FDA's recall record names no specific 510(k) clearance for this event. Product: SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051. Reason: Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals..
- Recalling firm
- DiaSorin Molecular LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-09-23
- Firm location
- Cypress, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.