Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051

FDA Recall Z-0162-2022 · Posted None

Recalling FirmDiaSorin Molecular LLC
Recall StatusOpen, Classified
Product CodeQJR
Date Initiated2021-09-23
Product Quantity1690 kits

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.

Firm Action

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 [email protected]. 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.

Root Cause

Process control

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑