Recall Z-0162-2022 ยท QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
DiaSorin Molecular LLC
SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
| Date | Sep 23, 2021 |
| Status | Open, Classified |
| Reason | Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals. |
| Root cause | Process control |
| 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.