Recall Z-1009-2022 ยท QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
MESA BIOTECH, INC
Accula SARS-CoV-2 Test, REF: COV4100
| Date | Apr 6, 2022 |
| Status | Open, Classified |
| Reason | SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment. |
| Root cause | Material/Component Contamination |
| Action | On 04/06/22, recall notices were mailed to customers. Customers were informed that the reliability of negative test results is not affected. Customers with affected devices were asked to do the following: 1. Discontinue use of any affected product immediately 2. All affected product must either be returned or discarded. Replacement product will be provided for all returned and discarded product upon receipt of Customer/Distributor Response Sheet. 3. Notify all impacted users in your facility. If you have shipped any of these lots outside of your facility, you must notify those customers or f |
| Quantity | 6162 |
| Distribution | US Nationwide distribution in the states of CA, TX, MA, NY, FL, NC, NJ, GA, CO, HI, PA, WA, NY, VA, MD, KY, WI, IL, PR, ND, MI, TN, AZ, UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.