SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
- Company
- Diasorin Molecular Llc
- Recall Initiated
- September 23, 2021
- Recall Number
- Z-0162-2022
- Quantity
- 1690 kits
- Firm Location
- Cypress, CA
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
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.
Lot / Code Info
Lot #/Expiration Date: 12175N/11.30.2021, 12722N/01.31.2022, X12122N/01.31.2022, X12724N/08.31.2022
Root Cause
Process control
Action Taken
On September 23, 2021, DiaSorin Molecular issued a field courtesy notification letter via email. On October 18, 2021, DiaSorin issued a "Urgent: Medical Device Correction" notification to provide additional details concerning the recall. In addition to informing consignees about the correction, DiaSorin asked consignees to take the following actions: 1. A run with a failed positive control should be repeated per the IFU instructions. 2. Please be sure to notify others within your network that may have received these kits. 3. Please complete and return the Acknowledgement and Receipt Form (page 2) of this notification letter. 4. If your firm has further distributed the devices, please share a copy of this correction notification and response form with those customers and provide a copy of the completed response form back us. 5. If you have any questions or if you have experienced an invalid Positive Control run and would like replacement product for the tests that were invalid due to this, please contact DiaSorin Molecular Technical Service, Mon-Fri, 7:00 AM to 5:00 PM (Pacific Time) at (800) 838-4548, option 3, or by email at ts.molecular@DiaSorin.com. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.