Recall Z-2508-2021 ยท QKO Reagent, Coronavirus Serological
Beckman Coulter Inc.
Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C74340 Access SARS-CoV-2 (1st IS) Quality Control (QC), REF C74341
| Date | Aug 5, 2021 |
| Status | Terminated |
| Reason | Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute |
| Root cause | No Marketing Application |
| Action | On 08/06/2021, the firm sent an initial "URGENT MEDICAL DEVICE RECALL" Notification informing its customers that due insufficient evidence the firm was not issued an Emergency Use Authorization for its SARS-CoV-2 IgG (1st IS) assay and required to discontinue distribution and to recall all affected products. On 09/13/2021 the firm sent a revised "URGENT MEDICAL DEVICE RECALL UPDATE" to inform its customers about the potential risks/harms related to using the affected products, such as, the assay may generate discordant results such as false positive, false negative or misinterpreted results w |
| Quantity | 303 kits (U.S.) and 964 kits (O.U.S.) |
| Distribution | U.S. Nationwide distribution in the states of AZ, CA, GA, IL, IA, KY, MI, NJ, NY, NC, OH, PA, Puerto Rico, TN, TX, VA, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.